Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.

 

1. What are the pricing principles and processes in your country?

Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing, reimbursement, and prior evaluation procedures.

The process for pricing decisions on originator drugs vary according to the type of medicinal product and intended market (outpatient vs. hospital and subject and not subject to medical prescription).

For original medicinal products subject to a medical prescription provided in outpatient and in pharmacies, an international reference pricing system is applied to define the maximum market price. The international reference pricing system uses a basket of several EU countries, which are defined annually by the Ministry of Health. The reference countries selected for the year 2022 are Spain, France, Italy, and Slovenia.

The maximum prices of original medicinal products subject to a medical prescription are subject to an annual revision, based on comparison with the prices approved in the reference countries.

The prices of original medicinal products which require no prescription (OTCs) are free – unless they are reimbursed.

 

2. What pricing models are currently being utilised in your country?

Generics subject to medical prescription are subject to specific pricing rules.

The maximum sales price of generics is set by reference to the price of the reference medicinal product. The price of the generics cannot exceed 50% of the maximum sales price of the reference medicinal product or 25% of that price, should the reference product’s ex-factory price be lower than €10. Generics are also subject to an annual price revision.

Generics which are not reimbursed and are sold to NHS Hospitals are also subject to a price approval and revision procedure. Under this regime, the price of the generic should be at least 30% lower than the price of the reference medicinal product.

Biosimilar medicinal products are defined by exclusion, i.e. a biosimilar medicinal product is a biological medicinal product which does not fulfil the conditions of the definition of a generic (amongst other, because of differences related to the raw materials or to the manufacturing processes).

Nevertheless, their regulation is similar to generic products in other regards. Biologic or biosimilar medicinal products do not follow a specific regime for the determination of their prices, therefore, if the biologic or biosimilar medicinal product is reimbursable under the applicable law, it may be subject to the regime of maximum prices as any other medicinal product.

 

3. What are the processes and principles around reimbursement approval?

There is a national reimbursement system of medicinal products that are provided outpatient and in pharmacies, in which the Government co-pays part of the price of the medicinal products prescribed to the users of the NHS. For a medicinal product to be reimbursed by the Government, the holder of the marketing authorization shall submit an authorization procedure for such purpose. There are four categories of reimbursement levels that range from a co-payment by the Portuguese State of 15% to 90%. In addition, there is also an exceptional reimbursement regime where some medicinal products duly specified may benefit from a 100% public financing.

 

4. What are the reimbursement approval processes and principles for generics and biosimilar drugs?

Where a generic is placed in the market, a “homogenous group” (“HG”), composed of medicinal products with the same active substance and dosage, is created. Consequently, a reference price will be approved for the products which are part of said HG. The reference price will be based on the average of the retail sales price of the five lowest-priced medicinal products included in the HG. Following the approval of said reference price, the maximum amount of reimbursement for products included in the HG will be determined by applying the applicable reimbursement percentage to the reference price. The maximum sales price of generics placed in the market upon the HG creation must be at least 5% lower than the price of the cheapest generic already in the HG and has at least a 5% market share of generic medicinal products in the HG.

Biosimilar medicinal products benefit from the reimbursement regime applicable to their reference biological medicinal product, without prejudice to any necessary adaptations.

If the biosimilar medicinal product is part of a HG of biosimilar medicinal products, the maximum retail price of new biosimilar medicinal product to be reimbursed must be lower than the lowest priced biosimilar medicinal product, it being necessary that the lowest priced biosimilar medicinal product has a certain percentage of the market share of the medicinal products of the homogeneous group. Said percentage, as well as the margin for the maximum retail price, are defined by the government on a case-by-case basis.

When the biosimilar medicinal product is not part of a HG, the maximum retail price of the biosimilar medicinal product may not be higher than 80% of the maximum retail price of the reference biologic medicinal product.

Moreover, some biologic medicinal products are subject to exceptional regimes of reimbursements, where the reimbursement fee is of 100%.

As for the prior evaluation agreements for biosimilar medicinal products, the economic advantage to be taken into account shall correspond to at least 20% of the direct price of the reference biological medicinal product.

A biosimilar medicinal product shall benefit from the reimbursement system, either general or special, applicable to the reference biological medicinal product, by means of a reimbursement contract, with the adaptations resulting from the market share of both medicinal products and the prices of each one.

Also from this Legal Handbook

Regulatory reforms to watch out for in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. Are there proposals for reform or significant change to the healthcare system?

As far as publicly made available by the Portuguese Government and Parliament, there is no proposals for reform or significant changes to the healthcare system.

In any case, with respect to health law in general, it is worth noting that, following the entry into force of Regulation (EU) 2017/245 on 26 May 2021, a new legal framework for medical devices is currently under preparation, which intends to update the applicable national law according to the European regulations.

 

2. When are they likely to come into force?

Initially, the new legal regime for medical devices was expected to enter into force on 26 May 2021, together with the Medical Devices Regulation, but the respective legislation hasn’t yet been published.

Based on Infarmed’s announcement regarding this matter, we understand that the proposal is still undergoing the applicable legislative procedure and should come into force in the upcoming weeks (or months).

 

Also from this Legal Handbook

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

The placing in the Portuguese market of products or substances based on cannabinoid drugs for medicinal purposes is subject to a specific authorization from Infarmed – National Authority on Medicines and Health Products (“Infarmed”). Moreover, the activities of cultivation, import, export, manufacturing, distribution, direct sale of cannabinoid drugs for medical purposes are also subject to specific authorization procedure before Infarmed.

The recreational use of cannabinoid drugs is still a crime in Portugal; however, private consumption is not penalized, as long as authorities find that the possessor is an occasional consumer.

 

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

Infarmed is the regulatory authority with powers to license and supervise all operations related to Cannabinoid Drugs for medicinal purposes such as cultivation, distribution, import, export, manufacturing and marketing authorisations.

In some cases, the law mandates non-binding participation of other public entities such as the Office for the Intervention against Additive Behaviour (SICAD) and other ministries.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

In July 2018, Law 33/2018, of 18 July (“Law 33/2018”) was published, and subsequently came into effect, legalizing the sale and use of cannabis and cannabis products for medical purposes. Under Law 33/2018, cannabis will be available only from pharmacies with a medical practitioner’s prescription. The entering into force of the Law 33/2018 was pending on the publication of the respective regulation that occurred in January 2019, through Decree-Law no. 8/2019, of 15 January (“Decree Law 8/2019”). Additionally, Decree Law 8/2019 also foresaw the publication of a ministerial order regulating the content of the requests and procedures for the issuing of authorizations to pursue activities related to cannabis, such as cultivation, manufacture, wholesale distribution, transit, import and export of cannabis based medicinal products, preparations and substances, as well as the cultivation of cannabis for industrial purposes. Accordingly, Ministerial Order no. 83/2021, of 15 April (“Ministerial Order 83/2021”) was published and sets out the aforementioned measures to be adopted.

These new laws are now the main legal framework for the activities in Portugal of cultivation, manufacture, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes.

These products may be authorised and placed in the market only for the therapeutic indications that have been previously approved by Infarmed.

The pricing of products based on cannabis for medical purposes is regulated by Ministerial Order 44-A/2019, which established a free pricing regime, but subject to an authorization of the price by Infarmed.

 

4. Which are the cannabinoid drugs that have received market approval to date?

According to the new legal framework described above one product has been approved, Dry Flower with THC, . However, there was already a medicinal product approved, Sativex, a prescribed mouth spray to alleviate neuropathic pain, spasticity, and other symptoms of multiple sclerosis, that is already in the market as a medicinal product.

 

5. Who can prescribe Cannabinoid Drugs?

Any doctor through a specific prescription form. However, prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

The prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects.

Moreover, Cannabinoid Drugs may only be prescribed for the therapeutic indications pre-approved by Infarmed (Deliberation no. 11/CD/2019).

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Any entity duly authorized by Infarmed for the activities of wholesale sale distribution of medicinal products and of cannabis for medical purposes.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is a public database, managed by Infarmed, of whom is licensed and authorized for the manufacturing, wholesale distribution and direct sale, but it does not display which entities distribute and/or sell Cannabinoid Drugs.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

The legalization and regulation of medicinal cannabis is very recent. The legalization was approved in July 2018, through Law 33/2018 and came into effect in January 2019 through the publication of additional regulation. This is was the main reform in this sector, and now with the publication of Ministerial Order 83/2021 on the applicable procedure for authorization requests, we do not anticipate any other significant changes in a near future.

The legalizing for recreational use will be discussed during in June 2021, at the Parliament, but it does not seem to have the support to be approved yet.

 

11. When are they likely to come into force?

Law 33/2018 entered into force in January 2019.

 

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

As mentioned above in 3., in January 2019 the legal framework that authorizes the commercialization in Portugal of cannabis and products based on cannabis for medical purposes came into force.

Since 1993, it was already possible, provided an authorization procedure before Infarmed was initiated, to cultivate, import and export cannabis for medical purposes, but only since January 2019 is it possible to market these products and distribute them in the Portuguese market.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Infarmed is the competent authority to regulate and supervise the cultivation, manufacturer, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

As mentioned in 3. above, the regulatory framework for the authorization of medicinal cannabis is set forth in Law 33/2018, that legalized the sale and use of cannabis and cannabis products for medical purposes and in Decree Law 8/2019, that regulated Law 32/2018. These new laws are now the main legal framework for the activities in Portugal of cultivation, manufacturer, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes, their authorization procedure and conditions being regulated by Ministerial Order 83/2021.

These products may be authorised and placed in the market only for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).

The pricing of these products is regulated by Ministerial Order 44-A/2019, which established a free pricing regime for all products based on cannabis for medical purposes, but subject to an authorization of the price by Infarmed.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Manufacturing and import activities are regulated and licensed by Infarmed.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The production of medicinal cannabis is subject to the following approvals:

• License for the cultivation, import and export of medicinal products to be provided by Infarmed and
• License for the manufacturing of medicinal cannabis products to be provided by Infarmed
• Certificate proving the prior authorization for each operation of import of plants, substances and preparations of cannabis to be provided by Infarmed

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

For the import of medicinal cannabis it is necessary to obtain a license from Infarmed for the undertaking of such activity and also an additional and specific authorization from Infarmed for each import transaction.

As mentioned in 3. above, the regulatory framework for the authorization of medicinal cannabis is set forth in Law 33/2018, that legalized the sale and use of cannabis and cannabis products for medical purposes and in Decree Law 8/2019, that regulated Law 32/2018. These new laws are now the main legal framework for the activities in Portugal of cultivation, manufacturer, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes.

 

18. How can patients obtain Medicinal Cannabis?

The cannabis and products based on cannabis for medicinal purposes may be obtained by the patients in pharmacies and with a specific prescription form issued by a doctor for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).

 

19. Who can prescribe Medicinal Cannabis?

Any doctor through a specific prescription form. However, prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No, all doctors can prescribe.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

The prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects and only for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).

 

22. Where is Medicinal Cannabis available?

Medicinal Cannabis products will be available only in pharmacies.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

The only retailers authorized are the pharmacies, and no specific or additional authorization or communication is necessary to be undertaken by the pharmacies. There is list at Infarmed’s website of all the pharmacies.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

The legalization and regulation of medicinal cannabis is very recent. The legalization was approved in July 2018, through Law 33/2018 and came into effect in January 2019 through the publication of additional regulation. This was the main reform in this sector, and now with the publication of Ministerial Order 83/2021 on the applicable procedure for authorization requests, we do not anticipate any other significant changes in the near future.

 

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Recreational use of Opioid Drugs is a crime in Portugal. However, private consumption has no penalty for occasional consumers, as long they possess a residual dose.

Moreover, medicinal products may, and some do, contain opioids and follow the authorization procedure for medicinal products, being subject to a special prescription form from a doctor.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Infarmed is the regulatory authority and competent body to license all operations related to the cultivation, import, export and distribution of Opioid Drugs for medical purposes.

In some cases, the law mandates non-binding participation of other public entities such as the Office for the Intervention against Additive Behaviour (SICAD) and other ministries.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Licenses and authorizations are regulated under Drug Fight Law and its regulation. On pricing and reimbursement of Opioid Drugs there are no specific regulations regarding pricing or reimbursement.

 

28. Which are the Opioid drugs that have received market approval to date?

There is a public database accessible by the public listing all opioid drugs. There is a public database in which all approved medicinal products are listed.

 

29. Who can prescribe Opioid Drugs?

Doctors, through a specific prescription form.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

All doctors can prescribe Opioid Drugs.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

A specific prescription form is required.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

The medicinal products containing opioids shall be distributed and sold in the same terms and conditions of medicinal products, which is by authorized distributors of medicinal products.

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is a public database, managed by Infarmed, of whom is licensed and authorized for the manufacturing, wholesale distribution and direct sale.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No. Ever since major legislative reforms in the 90s, Portugal has significantly diminished additive consume not linked to a therapeutic end. There has been no public debate in Portugal about drugs regulations other than Cannabis.

 

35. When are they likely to come into force?

NA.

 

Also from this Legal Handbook

An intro to the legal situation for orphan drugs and rare diseases in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. What is the definition of Rare Diseases in your country?

There is no legal definition for Rare Disease within the national legislation. However, within the European Union, diseases that affect less than five in ten thousand persons (5 in 10 000) are defined as Rare Diseases, sometimes called an orphan disease.

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Yes. Decree-Law 176/2006 refers to Regulation (EC) no 141/2000 of the European Parliament and of the Council of 16 December 1999, whereby a medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (i) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons (5 in 10 000) in the Community when the application is made, or (ii) that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment. (iii) Alternatively the sponsor can also establish that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

Orphan Drugs are governed by the regulatory framework specified on Regulation (EC) no 141/2000 of the European Parliament and of the Council of 16 December 1999. Although this regulation is from the European Union it is directly applicable in Portugal.

 

4. Does your country have pro- visions for relaxed clinical trial/ scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

Please refer to the previous answer.

 

5. Is there an expedited pathway for Orphan Drugs?

Under Regulation (EC) no 141/2000 Orphan Drugs Orphan Drugs are autho-rized by a centralized procedure with regards to their marketing authorizations evaluations.

The sponsor of an orphan medicinal product may also request protocol assistance to the European Agency for the Evaluation of Medicinal Products, such as advice from the Agency on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of the medicinal product. There is also support with all the fees payable under the applicable legislation.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Yes. With the implementation of Regulation EC No. 726/2004, all applications for marketing authorizations for drugs with orphan designation are mandatorily assessed through a centralized process. This represents access to a single EU market, since the medicinal product will be recognized as an orphan drug within all member states of the EU.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

Yes, Prices of drugs are regulated by the System of Assessment of Health Technologies (SiNATS). SiNATS was created by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing, reimbursement and prior evaluation procedures. There is no specific reimbursement procedure for orphan drugs.

 

8. How are the prices of Orphan Drugs regulated?

Please refer to the previous answer.

 

9. In case of reference price based on a basket of countries, what countries are included?

For a reference-based price the basket countries of reference consist of Spain, France, Italy and Slovenia (Ministerial Order 297/2020).

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

No.

Also from this Legal Handbook

The key legal info around regulation, pricing and reimbursement in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

Jurisdiction over drugs, biologicals and medical devices is centralized in Infarmed, the Portuguese Medicine Regulatory Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), hereinafter referred to as “Infarmed”.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is governed by the following laws and regulations:

1. Decree Law 176/2006, 30 August 2006 (Medicinal Products Act);
2. Regulation (EU) 2017/745, 5 April 2017 (Medical Devices Regulation);
3. Decree-Law 145/2009, 17 June 2009 (Medical Devices Act), on the matters not covered by the Regulation referred to in the previous paragraph;
4. Decree-Law 97/2015, 1 June 2015, Ordinance 195-A/2015, 30 June 2015, and Ordinance 195-C/2015, 30 June 2015 (Pricing and Reimbursement of medicinal products and medical devices).

 

3. What are the steps to obtain authorization to develop, test, and market a product?

In order to develop and test medicinal products in Portugal, it is necessary to obtain an authorization for the manufacturing of medicinal products and to comply with the requirements established in the Medicinal Products Act for the manufacturing of medicinal products.

In addition, a medicinal product to be marketed in Portugal must hold a marketing authorization obtained via one of the following methods: (i) National Procedure; (ii) Mutual Recognition Procedure; (iii) Decentralized Procedure; and (iv) Centralized Procedure at the European Medicines Agency.

 

4. What are the approximate fees for each authorization?

According to Ministerial Order no. 377,2005, of 4 April, as amended, the fee for the manufacturing authorization is approximately EUR 588.23.

The fees for the Marketing Authorization approval of the medicinal products are the following, depending on the type of procedure to be adopted (please refer to Chapter 1, Question 4):

National Procedure	EUR 2,915.55
National Procedure for Generics	EUR 1.759.56
Mutual-Recognition Procedure	EUR 5,115.00
Decentralized Procedure	EUR 3,069.00

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Marketing authorizations are valid for 5 (five) years. Renewals shall be applied for no later than nine months prior to the expiration date. After the first renewal, marketing authorizations are valid for an indefinite term. In the event of duly justified reasons related to pharmacovigilance, Infarmed may require an additional 5 (five) year renewal.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

According to the Medicinal Products Act, marketing authorization for generic products is subject to the same legal process as brand-name products.

However, for generic products the process may be shorter since the presentation of pre-clinical and clinical trials is not required, i.e., provided that (i) bioequivalence is demonstrated on the basis of bioavailability studies; or (ii) therapeutic equivalence is demonstrated by means of appropriate clinical pharmacology studies. This rule applies equally for both local and foreign-owned manufacturers.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

There are no specific regulation for combined products. However, biologics are classified as medicinal products (drugs) and are subject to the same rules established in the Medicinal Products Act. Therefore, the combination of products of medical devices and medicinal products implies that both products, individually, should obtain the respective authorizations.

Without prejudice to the above, medical devices intended to administer a medicinal product are regulated by the Medicinal Products Act, provided that they are placed on the market in such a way that the device and the medicinal product form a single integrated product which is intended to be used exclusively in this combination and which cannot be reused.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Compliance with regulation is monitored and evaluated by Infarmed, which ensures the supervision and enforcement of the legal provisions through (i) periodical inspections and (ii) audit and reporting requirements, including of adverse reactions under pharmacovigilance rules.

The regulatory regime is based on the EU directives on medicinal products and medical devices and is in line with the European Medicines Agency expectations and requirements.

 

9. What is the potential range of penalties for noncompliance?

The penalties for the market of medicinal products and medical devices consist of fines that may range between EUR 2,000 and 15% of the turnover, or EUR 180,000, whichever is lower, and other ancillary sanctions. The latter may be applicable in case of serious violations.

The ancillary sanctions may consist of: the suspension of the authorization or license granted to the entity that has committed the infraction up to a period of two years, loss in favor of the State of objects and equipment used by the defendant, and prohibition of participating in public tenders for a period of up to two years. These are only foreseen in the Medicinal Products Acts, therefore are only applicable in the case of penalties for the market of medicinal products.

In the particular case of medical devices, as of 28 July 2021, the offences under the Medical Devices Act will suffer a significant change and will be punishable under a different legal framework, as set out in Decree-Law 9/2021, 29 January 2021 (Legal Regime for Economic Offences). Under the terms of the referred new legal regime, the applicable fines may range between EUR 650 and EUR 24,000.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Portugal has a Social Security System with national healthcare coverage which is regulated by the Government through the Portuguese Ministry of Health (Ministério da Saúde). The National Health System (Serviço Nacional de Saúde), better known as NHS, covers all Portuguese residents; it is universal, comprehensive and nearly free at the point of use. The National Health System is financed primarily by general taxes.

The NHS can be characterized by:

• providing universal coverage;
• providing global healthcare in an integrated way or else guaranteeing its provision;
• usually being free to its users, taking into account the social and financial position of citizens;
• guaranteeing equal access to its users, with a view to mitigating the effect that economic, geographic or other inequalities have on access to healthcare;
• regionalized organization and decentralized and participative management.

The following persons are entitled to NHS coverage:

• all Portuguese nationals;
• nationals of member states of the European Union, the European Economic Area and Switzerland in accordance with the EU regulations in place;
• foreign nationals residing in Portugal, subject to reciprocity;
• foreign nationals residing in Portugal within the framework of bilateral agreements;
• citizens requesting asylum and refugee status;
• stateless citizens residing in Portugal.

Planning and regulation take place largely at the central level in the Ministry of Health and its institutions. The management of the NHS takes place at the regional level. In each of the five regions, a health administration board that is accountable to the Ministry of Health is responsible for strategic management of population health, supervision and control of hospitals, management of primary care centers and implementation of national health policy objectives.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

Hospitals belonging to the NHS – which include public hospitals and public hospitals managed by private entities (parcerias público-privadas) – are in the public sector, under the Ministry of Health’s jurisdiction. Private sector hospitals, both profit-making and non-profit-making, have their own management arrangements.

The Ministry of Health and regional health administrations may contract with private hospitals to provide healthcare services to the users of the NHS whenever this is advantageous, especially considering the quality-cost binomial, and provided that the right of access is guaranteed.

 

12. Are prices of drugs and devices regulated and, if so, how?

Prices of drugs are regulated by the System of Assessment of Health Technologies (SiNATS). SiNATS was created by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing, reimbursement and prior evaluation procedures.

Medicinal products subject to medical prescription are subject to a price approval procedure before Infarmed prior to launch on the Portuguese market.

In this respect, a maximum sale price is approved, which in the case of brand-name products is determined by reference to the price applied in three reference countries. This price is subject to an annual revision. Spain, France, Italy and Slovenia are the reference countries to be considered in  2021.

SiNATS foresees the possibility of administratively setting the sale prices of medical devices and of approving their reimbursement, as well as conditioning these products to a prior evaluation procedure, similar to that which exists for medicines, with a view to being used or purchased by National Health Service hospitals.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

There is a national reimbursement system of medicinal products, in which the Government co-pays part of the price of the medicinal products prescribed to the users of the NHS. In order for a medicinal product to be reimbursed by the Government, the holder of the marketing authorization shall submit an authorization procedure for such purpose. There are four categories of reimbursement levels that range from a co-payment by the State of 15% to 90%. In addition, there is also an exceptional reimbursement regime where some medicinal products duly specified may benefit from a 100% public financing.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

The sale of prescription drugs can only be made through pharmacies. The sale of OTC drugs can be made through both pharmacies and OTC retailers.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

In accordance with the Medicinal Products Act, a prescription drug can be prescribed by a doctor or, in cases specifically provided in the legislation, a dentist or an orthodontist and be dispensed by the hospital or through the pharmacies. The pharmacist shall dispense the products to the users in accordance with the medical prescription, or in case of OTC drugs, shall provide all the necessary information and indications of use to the users.

 

Also from this Legal Handbook

Preclinical and clinical trials in Portugal – a legal guide. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, clinical trials may be conducted abroad. In those cases, and whenever clinical trials are conducted outside the European Union, the applicant of the marketing authorization shall submit a declaration stating that the clinical trials carried out outside the European Union meet the ethical requirements set forth in the Portuguese legislation.

 

2. How are clinical trials funded?

The majority of the clinical trials conducted in Portugal are sponsored by the pharmaceutical industry, being the trials funded by the sponsoring companies.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

The clinical trials protocols shall describe the reasons, objectives, design, methodology, statistical considerations and organization of a clinical trial. The conducting of clinical trials in Portugal requires prior authorization from Infarmed and favorable opinion of the National Ethics Committee for Clinical Research (CEIC).

 

4. What are the requirements for consent by participants in clinical trials?

The consent of the participation in the clinical trials shall comply with the following requirements:

1. Participants should receive information, in a suitable language that they are able to understand, on the nature, scope, conditions and consequences and risks of the clinical trial;
2. Participants should receive information on their rights to withdraw from the trial, at any moment, and without consequences, including any implications in the healthcare services provided to the participant;
3. Consent should be obtained in writing.

 

5. May participants in clinical trials be compensated?

The Portuguese legislation on clinical trials prohibits the granting of financial incentives to trial participants. However, the participants may be reimbursed for any expenses or losses related to their participation in trials. The Portuguese Ethics Committee on Clinical Trials accepts the payment of lost wages as a result of their participation in the clinical trial, traveling and accommodation expenses, food, medical exams and any other expenses considered legitimate.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

Under Portuguese law, one of the conditions for conducting a clinical trial is the contracting of a civil liability insurance covering the civil liability that may arise from the sponsor and the investigator for the damages caused to the participant. Moreover, the civil liability of the sponsor and of the investigator is joint and objective, which means that the sponsor and the investigator may be liable even though there may be no fault in their performance.

 

Also from this Legal Handbook

All about marketing, manufacturing, packaging and labeling and advertising of drugs in Portugal. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

(i) Medicinal products

The marketing of any medicinal products, including new drugs, biologics and over-the counter medicinal products, is subject to prior marketing authorization from Infarmed.

The authorization shall be granted exclusively based on scientific criteria considering the quality, safety and therapeutic efficacy of the medicinal product.

The marketing authorization process shall be submitted online on Infarmed’s website. All the requested documentation and the communications between the applicant and Infarmed regarding the authorization process shall be only be e-mail.

 

(ii) Medical devices

The marketing process for medical devices is substantially different. In fact, the general rule on medical devices is that the manufacturer shall be liable for applying the CE Marking, which is a process that indicates that the medical device complies with European Union legislation on medical devices.

Once CE marking is obtained, and prior to the placement on the market, the medical device shall be notified to Infarmed (through a national online platform owned by the authority).

 

2. What is the authorization process for the marketing of generic versions of these products?

The generics of medicinal products follow the same authorization procedure to obtain the marketing authorization. However, in the generics case it is not necessary to submit, under the Marketing Authorization procedure, the results and documentation of the preclinical and clinical trials (Please refer to Question 6 of Regulatory, Pricing and Reimbursement Overview).

 

3. What are the typical fees for marketing approval?

The typical fees for the Marketing Authorization approval of the medicinal products are the following, depending on the type of procedure to be adopted (please refer to Question 4 of Regulatory, Pricing and Reimbursement Overview):

National Procedure	EUR 2,915.55
National Procedure for Generics	EUR 1,759.56
Mutual-Recognition Procedure	EUR 5,115.00
Decentralized Procedure	EUR 3,069.00

 

4. What is the period of authorization and the renewal process?

Please refer to Question 5 of Regulatory, Pricing and Reimbursement Overview.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

There is a national pharmacovigilance system managed by Infarmed. The holder of the marketing authorization shall implement and maintain an internal pharmacovigilance system following the same structure and requirements of the national system. The holder of the marketing authorization shall also appoint one person responsible for the pharmacovigilance and make available all the necessary documents for Infarmed regarding these matters.

 

6. Are foreign marketing authorizations recognized?

Only the marketing authorizations granted from other countries of the European Union. In these cases, the procedure to be adopted is the mutual-recognition which consists on a registration procedure of the medicinal products and much simpler than the national authorization procedure.

 

7. Are parallel imports of medicines or devices allowed?

The parallel import of medicinal products is allowed under the European Territory, provided that the following conditions are met:

1. (i) The medicinal product holds a valid marketing authorization from the European Member State of origin;
2. (ii) The medicinal product is commercialized in accordance with the Portuguese legislation;
3. (iii) The medicinal product shall be similar to the product under consideration (same active substance, form and therapeutic indication);
4. (iv) The import does not constitute a risk to public health.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

According to the Portuguese legislation, pharmaceutical companies are not allowed to, directly or indirectly, offer gifts to individual medical practitioners nor to their patients, except in the case of objects of low monetary (i.e. up to EUR 60 in value) and that are relevant for the practice of medicine or pharmacy and/or involve a benefit for the patient.

Sponsorships, consultancy agreements and travel and other benefits related to medical education do not qualify as gifts under the national legislation. However, there are very strict rules governing the offering of these benefits to individual medical practitioners by pharmaceutical companies. What’s more, both pharmaceutical companies as well as beneficiaries are required to report to Infarmed the amount granted as support or sponsorship, with a view to ensure transparency.

Regarding healthcare organizations, pharmaceutical companies may provide support, either financial or non-financial contributions, to these entities with the purpose of supporting healthcare services or research activities.

However, the healthcare services of the National Health Service, may only receive those gifts and donations from pharmaceutical companies or host scientific events sponsored by pharmaceutical companies in their premises if authorization is granted by Infarmed, in order to ensure that the grant of such support is not deemed to jeopardize the exemption and impartiality.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacturing of medicinal products is an activity subject to the prior authorization of Infarmed.

The manufacturing of medical devices is subject to a notification to Infarmed with a 60 days’ notice from the beginning of the manufacturing activity.

Additionally, in case manufacturers are the holders of the manufacturing plants/facilities of medicinal and devices, it is also subject to the general industrial license procedure to be granted by the Minister of Economy.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

The local manufacturing practices are in accordance with the guidelines issued by the European Medicines Agency.

 

11. What is the inspection regime for manufacturing facilities?

Infarmed is entitled to inspect the manufacturing facilities, whenever it deems necessary, and in particular, under a regular inspection and/or also based on any grounds on the breach of the legal requirements.

The competent services from the Minister of Economy may also conduct inspections to the facilities in coordination with Infarmed.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

No. The inspections shall be conducted by Infarmed employees. However, there may be inspections undertaken at the request of other agencies, including EMA and FDA.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

The storage, packaging and handling of medicinal products and medical devices shall comply with the good distribution practices of medicinal products set forth in Infarmed Deliberation 047/CD/2015.

The storage, packaging and handling of medical devices products and medical devices shall comply with good distribution practices set forth in Ordinance 256/2016.

 

14. What information must be included in medicine and device labeling?

The labelling of medicinal products shall contain the following information:

1. name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product;
2. active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
3. the pharmaceutical form and the contents by weight, volume or number of doses of the product;
4. list of those excipients known to have a recognized action or effect whose knowledge is necessary for the use of the product and if the product is injectable, or a topical or eye preparation, all excipients must be stated;
5. the method and, if necessary, the route of administration;
6. a special warning that the medicinal product must be stored out of reach of children;
7. the legal status for supply to the patient;
8. in the case of self-medication, instructions on the use of the medicinal products;
9. mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery;
10. if applicable, the expression “external use” printed in red;
11. expiry date, including month and year;
12. period of use after reconstitution of the medicinal product or after the first opening of the primary packaging, if applicable;
13. special storage precautions, if any;
14. special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate;
15. the price of the medicinal product;
16. the name and address of the holder of the authorization for placing the medicinal product on the market;
17. the number of the authorization for placing the medicinal product on the market;
18. the manufacturer’s batch number;
19. the expression “free sample”, or “prohibited sale to the public”, if applicable.

 

The information on the labelling of medical devices depends on the type of medical device. However, all medical devices shall contain the following information:

1. name and address of the manufacturer;
2. the information strictly necessary for the user to be able to identify the device and contents of the packaging;
3. if applicable, the expression “sterile”;
4. if applicable, the batch number;
5. if applicable, the deadline for safe use of the device, expressed in the year and month;
6. if applicable, indication that the device is for single use;
7. if applicable, the expression “custom made device”;
8. for devices intended for clinical investigations, the expression “exclusively for clinical investigation”;
9. special storage or handling conditions;
10. instructions for use;
11. any warning and cautions;
12. manufacturing year;
13. if applicable, sterilization process.
14. if applicable, a statement that the medical device incorporates as an integral part a human blood derivative.

 

15. What additional information may be included in labeling and packaging?

The medicinal products reimbursed by the State may include further information whenever deemed necessary.

 

16. What items may not be included in labeling and packaging?

Any items that may lead to an irrational use of the medicinal products.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

For medicinal products the most important rules and principles on the marketing and advertising are the following:

• The adverting shall encourage the rational use of medicinal products;
• The advertising shall not be misleading;
• The adverting to medicinal products shall be duly identified as such;
• It is forbidden the advertising of a medicinal product that does not hold a marketing authorization;
• Advertising shall be in accordance with the summary of product characteristics;
• It is forbidden to advertise before the general public medicinal products subject to medical prescription.

With the necessary adaptations, the same rules and principles apply to the advertising of medical devices.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicinal products subject to medical prescription may only be sold or delivered in community pharmacies or hospitals and healthcare establishments.

Medicinal products not subject to medical prescription may also be sold in other places rather than pharmacies, such as supermarkets and gas station, provided that such places comply with the applicable regulatory requirements and that are duly authorized before Infarmed. In addition, it is worth noting that in such places where medicinal products not subject to medical prescription are dispensed the sale of tobacco products is prohibited.

Regarding medical devices, there are no restrictions to their sale or delivery, except for invitro medical devices for self-diagnosis which may only be sold in pharmacies or other places authorized to sell medicinal products not subject to medical prescription.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

There are no specific legal rules on advertising on the Internet. Electronic marketing and advertising via email is therefore subject to the general legal framework applicable to the advertising of medicinal products.

 

20. May medicines and devices be advertised or sold directly to consumers?

Only non-prescription medicinal products may be advertised directly to consumers (Please see Traditional Medicines and OTC Products Questions 2 and 3). Medicinal products may be sold directly to consumers provided that, in the case of medicinal products subject to medical prescription, the prescription is delivered to the pharmacy.

We note that some medicinal products may only be delivered to patients in hospitals or healthcare establishments.

Regarding medical devices, the only prohibition on the direct-to-consumer advertising is regarding the medical devices that for the respective use it requires the mediation and decision of a healthcare professional.

 

21. How is compliance monitored?

Infarmed is the entity responsible for supervision and compliance with the commercialization of medicinal products, including the advertising of medicinal products and medical products.

The holders of marketing authorizations of medicinal products and other entities responsible for the medicinal products advertising shall send a piece of the advertising to Infarmed within 10 days after its first release. Moreover, pharmaceutical companies as well as the respective beneficiaries are required to report to Infarmed the amount granted (or received) as support or sponsorship, with a view to ensure transparency (Please refer to Question 8).

 

22. What are the potential penalties for noncompliance?

Please refer to Question 9 of Regulatory, Pricing and Reimbursement Overview.

 

Also from this Legal Handbook

Want to know more about traditional medicines and OTC products in Portugal? Read on! Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Traditional, herbal, complementary, or alternative medicines are subject to a registration procedure before Infarmed. The registration procedure may be national, based on a mutual recognition procedure or based on a decentralized process.

There are no specific regulations for traditional, herbal, complementary, or alternative medicines. Therefore, such medicines and devices are also regulated by the Medicinal Products Act.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, provided that the product in question is not subject to medical prescription and that it is not reimbursable by the National Health System.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Advertising to the public shall not include any information that:

• leads to the conclusion that no medical appointment or surgical procedure is necessary and that induces a certain diagnosis, or treatment by correspondence;
• suggests that the effect of the medicinal product is guaranteed, with no adverse reactions or side effects, with results greater or equivalent to those of another treatment or medicinal product;
• suggests that the person’s normal health condition may be improved by the use of the medicinal product;
• suggests that the person’s normal health condition may be impaired in case the medicinal product is not used (except for vaccination campaigns approved);
• is exclusively or mainly targeted at children;
• refers to a recommendation from scientists, healthcare professional or other persons, who because of their celebrity may encourage the consumption of medicinal products;
• suggests that the medicinal product is food, a cosmetic or personal hygiene product, or any other consumption product;
• suggests that the safety or efficacy of the medicinal product is due to the fact that it is a natural product;
• may lead to an erroneous self-diagnosis through a detailed description or representation of patient history;
• refers in inadequate, alarming or misleading terms to evidence or guarantee of recovery; and
• uses inadequate, alarming or misleading terms, representations of changes in the human body or parts of the human body, caused by diseases or injury or of the action of a medicinal product.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over the counter (OTC) medicinal products are governed by the rules of Decree-Law 134/2005, 16 August 2005, amended by Law 51/2014, and subject to the supervision of Infarmed. Regulatory requirements for OTC medications are the same as for prescription drugs, i.e. the Medicinal Products Act.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

The distribution and sale of OTC products may be carried out in pharmacies and OTC retailers (i.e. entities duly authorized by Infarmed to sell prescription medicines).

 

6. What health, advertising, and marketing claims may be made for OTC products?

Please refer to Questions 2 and 3.

 

7. Can OTC products be marketed or advertised directly to the public?

Yes, it is possible to advertise OTC medicines to the public, if such medicines are not reimbursable by the National Health System. Please refer to Questions 2 and 3.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

Medicinal products shall be subject to medical prescription when they are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision.

A prescription-only product can be converted to an OTC product when there is an OTC product with similar qualitative and quantitative composition, pharmaceutical form and indications.

The “switching” process can be triggered by an applicant’s request or directly determined by Infarmed.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Please refer to Question 7 of Marketing, Manufacturing, Packaging and Labeling, Advertising.

 

Also from this Legal Handbook

A brief overview of the situation regarding product liability in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. What types of liability are recognized in your jurisdiction?

The Portuguese legal system provides for two fundamental types of civil liability: liability arising from failure to comply with contractual obligations (contractual liability) and liability resulting from the infringement of fundamental rights or from the practice of certain acts that, although licit, cause harm to another (non-contractual liability).

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

The non-contractual liability includes the objective liability (as opposed to subjective liability based on guilt), based on the risk, which is an exceptional scheme and aims to cover certain activities which by their nature were considered to be dangerous because of an increased risk. There is one specific legal framework which establishes the objective liability for manufacturers of products, including medicinal products and medical devices: the manufacturer’s liability legal framework set forth in Decree-Law 383/89, 6 November 1989, amended by Decree-Law 131/2001 which governs the manufacturer’s liability, regardless of fault, for the damages caused by a defect in his product.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

The general principle governing civil liability of directors and other corporate executives, establishes that, any director that, wilfully or negligently, infringes another person’s right or a legal provision designed to protect the interests of others, is under the obligation to indemnify the aggrieved party for the damages arising from such infringement.

 

4. How can a liability claim be brought?

A liability claim shall be brought through judicial courts.

 

5. What defenses are available?

The general rule is that the complainant shall make evidence of the damages caused due to the guilty action of the defendant. However, in the specific case of the manufacturer’s liability, the complainant is exempted from proving the manufacturer’s guilt.

Moreover, in this legal framework the manufacturer may not be liable in case the following claims are evidenced: (i) the manufacturer did not put the product into circulation; or (ii) that, having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that this defect came into being afterwards; or (iii) that the product was neither manufactured by the manufacturer for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business; or (iv) that the defect is due to compliance of the product with mandatory regulations issued by the public authorities; or (v) that the state of scientific and technical knowledge at the time when the manufacturer put the product into circulation was not such as to enable the existence of the defect to be discovered; or (vi) in the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product.

 

Also from this Legal Handbook

Read all about the legal situation around patents and trademarks in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. What are the basic requirements to obtain patent and trademark protection?

The main Portuguese legal framework for industrial property rights is enshrined in the Industrial Property Code (CPI), as approved by Decree-Law 110/2018, of 10 December 2018 (as amended).

Portugal is a TRIPS-standard jurisdiction with a pre-grant opposition, absolute novelty patent system where all technical fields are eventually patentable.

According to CPI, any pharmaceutical product may be patent protected provided that it is (i) new; (ii) inventive; and (iii) industrially applicable.

As for trademarks, the basic requirements are distinctiveness of the sign and the lack of confusable registered trademarks or applications to identify competitive linked products or services.

 

2. What agencies or bodies regulate patents and trademarks?

Regulation over patents and trademarks is centralized at the Portuguese National Industrial Property Institute (Instituto Nacional da Propriedade Industrial), better known as INPI.

More information available at www.inpi.justica.gov.pt/.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Patents can protect:

• Products, substances or compounds used in surgery or therapy and diagnostic methods for treating the human body.
• New processes for obtaining new known products, substances or compositions.

 

Patents cannot protect:

• Discoveries, scientific theories and mathematical methods.
• Materials or substances already existing in nature and nuclear materials.
• Aesthetic creations.
• Schemes, rules or methods for intellectual acts, playing a game or doing business and computer programs.
• Presentations of information.
• Processes for cloning human beings.
• Processes for modifying the germinal genetic identity of human beings.
• The use of human embryos for industrial or commercial purposes.

 

The following can be registered as trademarks:

• a sign or set of signs which is capable of being represented graphically – in particular, words, including personal names, designs, letters, numerals, sounds or the shape of goods or their packaging – provided it is also capable of distinguishing the goods or services of one company from those of others.

 

The following cannot be registered as trademarks:

• Trademarks that are devoid of any distinctive character.
• Signs that exclusively consist of the form:
  • imposed by the nature of the product itself;
  • of the product necessary for obtaining a technical result; or
  • that confers a substantial value to the product.
• Signs that are exclusively made up of indications that may serve in commerce to designate the type, quality, quantity, purpose, value, geographic origin, period or means of production of the product or the service, or other characteristics of it.
• Trademarks that exclusively consist of signs or indications that have become common use in modern-day language or in the habitual and constant habits of commerce.
• Colours, except those that are combined with graphics, wording or other particular and distinctive elements.

 

4. How can patents and trademarks be revoked?

A patent can be revoked by a court and in specific cases by the Portuguese National Industrial Property Institute, following a request by the Public Prosecutor’s office or by any interested party, including the patentee, on any of the following grounds:

• The object of the patent cannot be protected.
• If, when granted, procedures or formalities essential to the grant of the right were omitted.
• If public rules were breached.
• If the right does not belong to the patent holder.
• Failure to pay fees.
• Renunciation by the patent holder.
• If the patent is not exploited within four years of the date of the patent application or three years of the grant date, whichever is later, a third party can apply to the INPI for the grant of a compulsory license relating to the patent.

 

A trademark can be revoked on the following grounds:

• The trademark was not the object of serious use for a period of five consecutive years.
• The grounds for registration were not fulfilled.
• The trademark may mislead the public, particularly as to the quality, nature or origin of the goods or services.

 

5. Are foreign patents and trademarks recognized and under what circumstances?

In each of the contracting states for which it is granted, a European patent has the effect of and is subject to the same conditions as a national patent granted by that state, unless otherwise provided in the European Patent Convention (EPC).

If the European patent is not validated in Portugal, then it has no effect in Portugal and it cannot be enforced through the Portuguese courts.

For a Trademark European Community registry request, it is necessary to fill an appropriate form made available by European Union Intellectual Property Office (EUIPO), in which the request process is singular and centralized. An international request should be made to the World Intellectual Property Organization (WIPO), through the National Institutes, i.e., in Portugal to INPI or EUIPO.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

The Medicinal Products Act provides exclusivity periods for medicinal products according to the “8+2+1” approach in Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as follows:

During the first 8 years from the grant of the originator company’s marketing authorization, data exclusivity applies.

After the 8 years have expired, a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.

After a period of 10 years from the grant of the originator company’s marketing authorization, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity.

This additional 1 year may be obtained in a number of circumstances, such as where the innovator company is granted a marketing authorization for a significant new indication for the relevant medicinal product. In such a situation, the generic company can only market their product after 11 years from the grant of the innovator company’s marketing authorization.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

There are no restriction of medicines or devices that could be protected through patents or trademarks different from the ones already described.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

License agreements do not require a government approval; however, licenses must be draw up in writing and if the grant of sublicenses is not authorized by license, these can only be granted with the written authorization of the right holder.

In order to be made enforceable against third parties, License agreements must be registered before the Portuguese National Industrial Property Institute.

 

Also from this Legal Handbook

Want to know more about localization in Portugal? Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

Generally, in the pharmaceutical sector, there are no rules and policies requiring localization in Portugal.

However, it is worth noting that market operators that intend to carry out specific activities in the Portuguese territory are required to be authorized and/or registered with the Portuguese Medicines Authority (Infarmed), as follows:

• The manufacture (in whole or in part) of medicinal products, also including the operations of division, packaging, primary or secondary, or fill-finish, is subject to a specific authorization issued by Infarmed.
• The manufacture and distribution of pharmaceutical ingredients (i.e. active substances) is subject to registration with Infarmed.
• The wholesale distribution of medicinal products is subject to a specific authorization issued by Infarmed.
• The importation (i.e. to or from countries outside the EU) of medicinal products is subject to a specific authorization issued by Infarmed.
• The parallel importation (i.e. from countries within the EU) of medicinal products is subject to a specific marketing authorization issued by Infarmed.

In another perspective, in order to obtain a marketing authorization or to conduct a clinical trial in Portugal, market operators shall comply with specific requirements impacted by localization. On the one hand, with respect to marketing authorizations, the applicant shall have its registered office in the EU. Additionally, if results of pharmaceutical, pre-clinical and clinical trials are required for the application and these were conducted outside the EU, the applicant shall submit a declaration stating that the clinical trials meet the ethical requirements set forth in the Portuguese legislation.

On the other hand, with respect to the conduction of clinical trials within national territory and without prejudice to other specific requirements, the sponsor (or its legal representative) is shall have its registered office within the EU.

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

No.

 

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

In order for a medicinal product to be marketed in Portugal, a marketing authorization from the national authority (Infarmed) is required. Furthermore, foreign authorizations are not automatically recognized, unless the authorization has been issued by the European Commission through the centralized procedure which is then valid within the European Union.

 

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the pricing process is not impacted by localization policies.

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the reimbursement is not impacted by localization policies.

 

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No: the access to public or public tenders of pharmaceutical products is not limited to national or European entities.

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?

The importation of medicinal products is impacted by localization rules in the following terms:

• The importation (i.e. to or from countries outside the EU) of medicinal products is subject to a specific authorization issued by Infarmed.
• The parallel importation (i.e. from countries within the EU) of medicinal products is subject to a specific marketing authorization issued by Infarmed.

With respect taxation, the Portuguese legal framework foresees fees specifically applicable on the marketing of medicinal products (currently the fee corresponds to 0.4% on the reference price of the medicinal product).

 

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

Economic or tax incentives to locate companies in Portuguese territory may arise from time to time, and may be national in scope or may originate from European projects/actions (e.g. Portugal 2020 or SIFIDE).

These incentives are usually temporary and vary over time, but are not specifically redirected to the pharmaceutical sector.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

As far as publicly made available by the Portuguese Government and the Portuguese Parliament, there no discussions in course.

Also from this Legal Handbook

Key legal info on biosimilars & biologics in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

 

 

1. Are biosimilar medicines considered the same as generic medicines in your country?

Biosimilar medicines are defined by exclusion, i.e. a biosimilar medicine is a biological medicine which does not fulfil the conditions of the definition of a generic medicine (amongst other, because of differences related to the raw materials or to the manufacturing processes). Nevertheless, their regulation is similar to generic medicines in other regards.

 

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

Biologic medicines are patentable. Biosimilar medicines however cannot be patented since according to the Industrial Property Code pharmaceutical products may only be patented provided that they are new, inventive and have an industrial applicability.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

According to the Medicinal Products Act, biosimilar medicines follow the same authorization procedure to obtain a marketing authorization for generic medicines, although with some adaptions.

The most relevant difference is that for the obtainment of a marketing authorization of a biosimilar medicine, it is necessary to provide results of appropriate pre-clinical or clinical trials related to the conditions that determine that the medicine does not fit the definition of a generic medicine (for example, related to the raw materials or manufacturing processes). However it is not necessary to present results of other tests and trials related to the reference medicinal product.

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

Besides the normal data required to obtain approval for a drug there are some special requirements for biologics drugs including biosimilar drugs, as stated above. These are provided in Annex I of Decree-Law 176/2006.

For example, it may be necessary to present additional data (e.g. the toxicological and clinical profile) if, based on the information already provided for generic medicines, it is not possible to demonstrate the similar nature between two biologic medicines.

In principle, the requirements are the same for biologic and biosimilar drugs, whereby the data to be provided is established on a case-by-case basis. However, if the biologic drug has more than one therapeutic indication, the efficacy and safety of the biosimilar medicinal product must be justified or, if necessary, demonstrated separately for each of the claimed indications.

If the biologic medicine is a plasma-derived medicinal product, the required data includes information regarding the basic substances and raw materials used. In these cases, a Plasma Master File (PMF) may be used.

 

5. What are the requirements for the choice of the reference comparator product?

Other than the general requirements (e.g. demonstrated bioequivalence to the reference biologic medicinal product, same pharmaceutical form, etc.), there are no specific requirements foreseen in Portuguese law.

For the purposes of prior evaluation agreements and reimbursement matters, medicines (including biosimilar and biologic medicines) must be subjected to a pharmacoeconomic and pharmacotherapeutic evaluation.

According to Ministerial Order no. 391/2019, of 30 October and Infarmed’s methodology instructions, the pharmacoeconomic evaluation to be made should be based on a comparison between the biosimilar/biologic medicine and all other options relevant to the disease or clinical condition in question (regardless of its efficacy levels), therefore the choice of comparator is very comprehensive for these purposes. The most efficient alternative to the biosimilar/biologic medicine is the one used to carry out the economic evaluation.

As for the pharmacotherapeutic evaluation, the comparator of the biologic/biosimilar product must be:

• Commonly used in clinical practice;
• Validated by scientific evidence for the indication/population in question, including regarding its efficacy and safety;
• The dosage and administration indications of the comparator must be in accordance with the summary of characteristics of the medicine;
• Covered by a financing decision, marketed and have a reported consumption.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

The requirements are the same whether the comparator product is from Portugal or from another regulatory jurisdiction.

However, for the purposes of prior evaluation agreements and reimbursement matters and underlying the economic evaluation, only comparators available in Portugal shall be used.

 

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

The System of Assessment of Health Technologies (SiNATS), created by the Decree-Law 97/2015, regulates the pricing of medicines.

Biologic or biosimilar medicines do not follow a specific regime for the determination of their prices, therefore, if the biologic or biosimilar medicine is reimbursable under the applicable law, it may be subject to the regime of maximum prices as any other medicinal product.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

Biosimilar medicines benefit from the reimbursement regime applicable to their reference biological medicine, without prejudice to any necessary adaptations.

If the biosimilar medicine is part of a homogenous group of biosimilar medicines, the maximum retail price (“MRP”) of new biosimilar medicine to be reimbursed must be lower than the lowest priced biosimilar medicine, it being necessary that the lowest priced biosimilar medicine has a certain percentage of the market share of the medicines of the homogeneous group. Said percentage, as well as the margin for the MRP, are defined by the government on a case by case basis.

When the biosimilar medicine is not part of a homogeneous group, the MRP of the biosimilar drug may not be higher than 80% of the MRP of the reference biologic drug.

Moreover, some biologic drugs are subject to exceptional regimes of reimbursements, where the reimbursement fee is of 100% (Ordinances no. 48/2016 and 281/2017).

As for the prior evaluation agreements for biosimilar medicines, the economic advantage to be taken into account shall correspond to at least 20% of the direct price of the reference biological medicine.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Biosimilar competition may impact its own reimbursement policy and/or pricing regime, but not of the reference product.

If there is a biosimilar medicine under a given International Non-Proprietary Name with at least 5 % market share of the respective active substance, the MRP of the biosimilar medicine may not be more than 70% of the MRP of the reference biologic medicine.

As for the prior evaluation agreements, the economic advantage to be taken into account must correspond to at least 30% of the direct price of the reference biological medicine if there is a biosimilar medicine under a given International Non-Proprietary Name with at least 5 % market share of the respective active substance.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

The prescription and dispensing of the biosimilar medicines specified in Ordinance 48/2016 can only be made in specialized consultations for diagnosis and treatment of certain diseases, by pharmaceutical services of the hospitals of the National Health System which are recognized by the competent authorities for such purposes (Prescribing Centers for Biological Agents).

In the case of the biosimilar medicines specified in Ordinance 281/2017, these medicines may only be prescribed by medical specialists of the areas of rheumatology, internal medicine and paediatrics, but may be dispensed in all pharmacies.

Other than in these cases, no specific regime is foreseen for the prescribing and dispensing of biologic or biosimilar medicines.

 

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

The Portuguese Medicinal Products Act and Ordinance no. 224/2015, of 27 July already foresee such a scheme, whereby the physician is obliged to reference the International Non-Proprietary Name of the active substance when prescribing a medicine, and not the commercial name of the medicine.

Therefore, when dispensing a medicine, pharmacists are obliged to inform the patient of the existence of medicines with the same active substance, pharmaceutical form, presentation and dosage of the prescribed medicine, as well as to inform of the existence of medicines that are reimbursed by the NHS and of the one with the lowest price available in the market.

The patient is free to choose which medicine to acquire, except for the cases when the physician has indicated in the prescription the technical reasons (exclusively the ones provided for in the law) which impede the substitution of the medicine that was prescribed with a commercial denomination for another medicine.

Other than this, the physician may only indicate the commercial name of the medicine when prescribing it if the medicine is not subject to reimbursement by the State, but even then, upon dispensing of the medicines, the pharmacist must present the patient with other viable options as stated above, and the patient is free to choose which medicine to buy.

 

12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

There is a national pharmacovigilance system managed by Infarmed. The holder of the marketing authorization shall implement and maintain an internal pharmacovigilance system following the same structure and requirements of the national system, implementing risk management plans and conducting post-approval studies. The holder of the marketing authorization shall also appoint one person responsible for the pharmacovigilance and make available all the necessary documents for Infarmed regarding these matters.

These requirements as with any other medicinal products, and are also the same for biologic and biosimilar medicinal products.

More specifically, the risk management plan of the biosimilar medicinal product shall take into account the security profile of the reference biologic medicinal product. Moreover, it is especially important that any notification of an adverse event includes a clear identification of the medicinal product and its batch (be it biosimilar or biological).

 

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

There are no specific requirements foreseen in Portuguese law.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

No.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

No.

 

1. Please describe the main cost containment policies in place in your country and their fundamental principles

 

a. Pricing and impact of generic/biosimilar approval

Currently there are no policies in place in this regard.

 

b. Clawback/Payback/Discounts/Rebates

In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated by Decree-Law No. 97/2015 of June 1.

The prior evaluation refers to prescription medicinal products that are intended to be purchased by hospitals and entities of the NHS. In practical terms, through the prior evaluation, Infarmed and pharmaceutical companies agree on a payback mechanism for each pharmaceutical product, i.e. on a maximum annual expenditure the Portuguese State is available to make for the use of a particular medicinal product; when such maximum annual expenditure is exceeded, pharmaceutical companies refund the Portuguese State, through the issue of credit notes in favour of the hospitals and entities of the National Health Service.

 

c. Existence of Price/Volume agreements in the frame of public tendering

Aside from the prior evaluation mechanism, within public tendering, and public procurement procedures in general, it is usual that pharmaceutical companies and public entities enter into commercial agreements, whereby the pharmaceutical company undertakes to grant to the public entity a discount/rebate when a certain volume of sales is reached.

In Portugal, these agreements consist of commercial practices of market operators, but do not constitute governmental policies and they are not imposed to pharmaceutical companies.

 

d. Existence of price freezes and cuts

Not applicable.

 

e. Post-launch monitoring of prescriptions/sales

Not applicable.

 

f. Existence of Generic Substitution Policies

According to the dispensing rules in force in Portugal, pharmacists shall dispense generic medicinal products in substitution of original medicinal products, without prejudice to the customer’s right to choose the original medicinal product.

 

g. At prescriber level

According to the prescription rules in force in Portugal, prescribers shall prescribe medicinal products based on the International Non-proprietary Name (INN) and they can only opt for prescription by the commercial name of the medicinal product or the marketing authorization holder in exceptional situations, namely when the original medicinal products does not have a reimbursed generic medicinal product.

 

h. At retail level

Not applicable.

 

2. Are there any other policies in place aiming at cost control via incentive programs targeting the different actors (pharma companies, wholesalers, retailers, prescribers etc)?

There are no relevant policies to be highlighted.

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1. Please make a general introduction to the public health sector in your country and its organization

The Public sector is composed of the National Health Service (Serviço Nacional de Saúde), also referred as the NHS, and the central and regional health services which integrate the NHS, amongst other relevant administrative companies and health services. The healthcare services provided by the healthcare establishments of the public sector tend to be free of charge to patients. These services are financed by government funds as defined in the national budget, compulsory tax contributions and user rates charged to patients – except for cases of waiver or exemption of payment of these rates.

Hospital medicine is free-of-charge for patients. Within the primary sector, patients have to pay part of the bill for prescription medicines at local pharmacies. 

The companies placing the medicinal products on the Danish market are in principle free to set the prices for the medicinal products both within the primary sector and the secondary sector. 

However, the unrestricted pricing is to a certain extent influenced by pricecap agreements negotiated every four years by the Ministry of Health, the Danish Regions, and the Danish Association of the Pharmaceutical Industry (Danish: Lægemiddelindustriforeningen or Lif). For more information on the price-cap agreements please see section III below.

 

2. Please provide any infographics including

a. The actors involved in the market access process (market authorization, pricing decisions, reimbursement decisions) 

b. The information and data required

 

c. The process and flow

Submission > Pharmacotherapeutic Assessment > Economic Assessment > Negotiation > Recommendation > Decision

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1.Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities?

The most relevant administrations, bodies and institutions in charge of public health in Portugal are:

• Ministry of Health (Ministério da Saúde), whose responsibility is, amongst others, to formulate, conduct, execute, and evaluate the national health policy;

• Directorate-General of Health (Direção Geral da Saúde), whose responsibilities are to plan, regulate, direct, coordinate and supervise all health promotion, disease prevention and healthcare activities, institutions and services, whether or not they are integrated into the NHS. It is also responsible for public health programs, quality and epidemiological surveillance, health statistics and studies;

• Central Administration of Health System (Administração Central do Sistema de Saúde), whose mission is to ensure the management of the financial and human resources of the Ministry of Health and the NHS, as well as the NHS facilities and equipment. In addition, it is responsible for defining and implementing policies, standards, regulations and integrated health planning, promoting innovation and efficiency in the NHS;

• Regional Health Administrations (Administrações Regionais de Saúde), which are responsible for implementing national health policy regionally, and coordinating all levels of healthcare.

• Executive Board of the National Health Service (Direção Executiva do Serviço Nacional de Saúde), entity recently incorporated that will coordinate and manage the assistance provided by the NHS, ensuring its functioning in a network, the continuous improvement of access to healthcare, the participation of users and the alignment of clinical and health governance.

2. Which are the administrations, bodies and institutions in charge of drug approvals in your country and what are their respective responsibilities?

Infarmed – National Authority of Medicines and Health Products, I.P (“Infarmed”), whose main goal is to ensure the quality, safety and efficacy of medicinal products and the quality, safety and performance of health products in order to avoid the risks of their use while ensuring adequate standards of public health and consumer’s protection.

3. Which are the administrations, bodies and institutions that qualify as “payers” in your country and what are their respective responsibilities?

• The Government, whose mission is to ensure the management of human and financial resources of the Ministry of Health and the NHS, as well as its equipment and infrastructures;

• Insurance companies, whose responsibility is to provide access to medical care in the private sector;

• The public and private healthcare subsystems, such as ADSE, which guarantees the effective access to social protection regarding healthcare services to public administration workers and their families.

 

4. Which are the administrations, bodies and institutions in charge of pricing decisions in your country and what are their respective responsibilities?

Infarmed, whose mission is to regulate, evaluate, authorize, discipline, supervise, and ensure the surveillance and control of research, production, distribution, commercialization, and use of medicinal products for human use and health products.

 

5. Which are the administrations, bodies and institutions in charge of reimbursement decisions in your countries and what are their respective responsibilities?

• Infarmed is also responsible for evaluating medicinal products for reimbursement purposes;

• The Ministry of Health is responsible for the reimbursement decision, although said power may be delegated to Infarmed.

6. Which are the administrations, bodies and institutions in charge of Health Technology Assessment in your countries and what are their respective responsibilities?

Health Technology Assessment is undertaken by two commissions of Infarmed, namely:

• The Commission on Health Technology Assessment (CATS) is an advisory body of Infarmed, composed of a pool of experts that are responsible for the assessment of the clinical and economic value of new health technologies, including medicinal products;

• The Directorate of Health Technology Assessment (DATS) is a department within Infarmed, responsible for managing the whole System of Assessment of Health Technologies (SiNATS), including the interaction between the marketing authorization holders, the CATS and the executive board of Infarmed.

7. Which are the administrations, bodies and institutions in charge of public procurement and tendering in your country and what are their respective responsibilities?

• Institute of Public Markets, Real Estate and Construction (IMPIC) is a public institute responsible for the supervision of public procurement, as well as public markets and construction and real estate sectors;

• The Court of Auditors (TC) is a supreme audit institution with several responsibilities. In regards public procurement matters, the Court of Auditors supervises public agreements and, in particular, is responsible for conducting a prior assessment and approval before some public agreements are executed, as these agreements represent a public expense;

• SPMS – Serviços Partilhados do Ministério da Saúde, which manages and centralizes public procurement procedures for some entities of the NHS.

 

8. What are the other actors of significance with regards to market access in your country and what are their respective responsibilities?

Infarmed and the Ministry of Health, as the entity responsible for the reimbursement decision.

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1. What are the pricing models, processes and principles for originator drugs?

Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing, reimbursement, and prior evaluation procedures.

The process for pricing decisions on originator drugs vary according to the type of medicinal product and intended market (outpatient vs. hospital and subject and not subject to medical prescription).

For original medicinal products subject to a medical prescription provided in outpatient and in pharmacies, an international reference pricing system is applied to define the maximum market price. The international reference pricing system uses a basket of several EU countries, which are defined annually by the Ministry of Health. The reference countries selected for the year 2022 are Spain, France, Italy, and Slovenia.

The maximum prices of original medicinal products subject to a medical prescription are subject to an annual revision, based on comparison with the prices approved in the reference countries.

The prices of original medicinal products which require no prescription (OTCs) are free – unless they are reimbursed.

 

2. What are the pricing models, processes and principles for generics and biosimilars drugs?

Generics subject to medical prescription are subject to specific pricing rules.

The maximum sales price of generics is set by reference to the price of the reference medicinal product. The price of the generics cannot exceed 50% of the maximum sales price of the reference medicinal product or 25% of that price, should the reference product’s ex-factory price be lower than €10. Generics are also subject to an annual price revision.

Generics which are not reimbursed and are sold to NHS Hospitals are also subject to a price approval and revision procedure. Under this regime, the price of the generic should be at least 30% lower than the price of the reference medicinal product.

Biosimilar medicinal products are defined by exclusion, i.e. a biosimilar medicinal product is a biological medicinal product which does not fulfil the conditions of the definition of a generic (amongst other, because of differences related to the raw materials or to the manufacturing processes). Nevertheless, their regulation is similar to generic products in other regards.

 

Biologic or biosimilar medicinal products do not follow a specific regime for the determination of their prices, therefore, if the biologic or biosimilar medicinal product is reimbursable under the applicable law, it may be subject to the regime of maximum prices as any other medicinal product.

 

3. What are the reimbursement approval processes and principles for originator drugs?

There is a national reimbursement system of medicinal products that are provided outpatient and in pharmacies, in which the Government co-pays part of the price of the medicinal products prescribed to the users of the NHS. For a medicinal product to be reimbursed by the Government, the holder of the marketing authorization shall submit an authorization procedure for such purpose. There are four categories of reimbursement levels that range from a co-payment by the Portuguese State of 15% to 90%. In addition, there is also an exceptional reimbursement regime where some medicinal products duly specified may benefit from a 100% public financing.

 

4. What are the reimbursement approval processes and principles for generics and biosimilar drugs?

Where a generic is placed in the market, a “homogenous group” (“HG”), composed of medicinal products with the same active substance and dosage, is created. Consequently, a reference price will be approved for the products which are part of said HG. The reference price will be based on the average of the retail sales price of the five lowest-priced medicinal products included in the HG. Following the approval of said reference price, the maximum amount of reimbursement for products included in the HG will be determined by applying the applicable reimbursement percentage to the reference price. The maximum sales price of generics placed in the market upon the HG creation must be at least 5% lower than the price of the cheapest generic already in the HG and has at least a 5% market share of generic medicinal products in the HG.

Biosimilar medicinal products benefit from the reimbursement regime applicable to their reference biological medicinal product, without prejudice to any necessary adaptations.

If the biosimilar medicinal product is part of a HG of biosimilar medicinal products, the maximum retail price of new biosimilar medicinal product to be reimbursed must be lower than the lowest priced biosimilar medicinal product, it being necessary that the lowest priced biosimilar medicinal product has a certain percentage of the market share of the medicinal products of the homogeneous group. Said percentage, as well as the margin for the maximum retail price, are defined by the government on a case-by-case basis.

When the biosimilar medicinal product is not part of a HG, the maximum retail price of the biosimilar medicinal product may not be higher than 80% of the maximum retail price of the reference biologic medicinal product.

Moreover, some biologic medicinal products are subject to exceptional regimes of reimbursements, where the reimbursement fee is of 100%.

As for the prior evaluation agreements for biosimilar medicinal products, the economic advantage to be taken into account shall correspond to at least 20% of the direct price of the reference biological medicinal product.

A biosimilar medicinal product shall benefit from the reimbursement system, either general or special, applicable to the reference biological medicinal product, by means of a reimbursement contract, with the adaptations resulting from the market share of both medicinal products and the prices of each one.

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1. Price

1.1. How does price control at ex-factory prices work in your country?

Ex-factory prices (PVA) are relevant to determine the retail price (PVP) of medicinal products and their maximum legal margins, as below.

 

1.2. What are the pricing models, processes and principles for generics and biosimilars drugs?

The maximum price margin of medicinal products varies according to their ex-factory prices, as follows:

• Ex-factory price equal to or less than €5:
  • Wholesalers – 2.24 %, calculated over the ex-factory price, plus €0.25;
  • Pharmacies – 5.58 %, calculated over the ex-factory price, plus €0.63;

• Ex-factory price equal to or less than €5:
  • Wholesalers – 2.24 %, calculated over the ex-factory price, plus €0.25;
  • Pharmacies – 5.58 %, calculated over the ex-factory price, plus €0.63;

• Ex-factory price from (euro) 5,01 to €7:
  • Wholesalers – 2.17 %, calculated over the ex-factory price, plus €0.52;
  • Pharmacies – 5.51 %, calculated over the ex-factory price, plus €1.31;

• Ex-factory price from €7,01 to €10:
  • Wholesalers – 2.12 %, calculated over the ex-factory price, plus € 0.71;
  • Pharmacies – 5.36 %, calculated over the ex-factory price, plus €1.79;

• Ex-factory price from (euro) 10,01 to €20:
  • Wholesalers – 2.00 %, calculated over the ex-factory price, plus €1.12;
  • Pharmacies – 5.05 %, calculated over the ex-factory price, plus €2.80;

• Ex-factory price from (euro) 20,01 to €50:
  • Wholesalers – 1.84 %, calculated on the ex-factory price, plus €2.20;
  • Pharmacies – 4.49 %, calculated on the ex-factory price, plus €5.32;

• Ex-factory price greater than €50:
  • Wholesalers – 1.18 %, calculated on the ex-factory price, plus €3.68;
  • Pharmacies – 2.66 %, calculated on the ex-factory price, plus €8.28.

 

1.3. How does price control at the retail pharmacy level work in your country?

Please refer to the question above.

 

2. External Reference Pricing (ERP)

2.1. Is there a system of external reference pricing (ERP) in place in your country?

Yes.

 

2.2. When and/or how often is ERP activated?

ERP is activated to define the maximum price of a prescription medicinal products, that was obtained a marketing authorisation, and that are provided outpatient and in pharmacies.

 

2.3. What is the legal framework of the ERP in place in your country?

The ERP is governed by Decree Law n. º 97/2015 of 1 June 2015.

 

2.4. What is the composition of the country basket?

The reference countries are defined annually by the Ministry of Health. The reference countries selected for the year 2022 are Spain, France, Italy, and Slovenia.

 

2.5. Describe the price calculation and selection for reference products.

The retail prices of medicinal products to be placed for the first time in the Portuguese market shall not exceed the average resulting from the comparison with the prices in force in the reference countries for the same medicinal product.

The retail price shall be calculated without taxes and duties applicable in the countries of reference, plus the commercialisation margins, taxes, and duties in force in Portugal.

The retail price of generics corresponds to a percentage of the retail price authorized in Portugal for the reference medicinal product or, in the absence of such medicine, in the terms referred to original medicinal products.

 

2.6. How often does the price need to be updated?

The prices of medicinal products are reviewed annually, based on a comparison with the prices charged in the reference countries.

The medicinal products prices may also be exceptionally reviewed for reasons of public interest or at the initiative of the marketing authorization holder.

 

2.7. How do the “price List”/catalogues from references countries work in your country?

Please refer to the previous questions.

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1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?

The CATS and the DATS are responsible for SiNATS.

 

2. Do regulators require HTA studies in your country?

Yes, regulators may require HTA studies. Moreover, the information contained in SiNATS and the studies that support HTA decisions are published in accordance with the conditions to be defined by Infarmed.

 

3. Do payers require HTA studies in your country?

Thought not mandatory, payers are allowed to require HTA studies in Portugal.

4. How are HTA assessments translated into pricing conditions in your country?

HTA assessment is the basis for (i) deciding on the price, reimbursement, acquisition, or installation of health technologies and (ii) deciding on the maintenance of reimbursement or acquisition, through prior evaluation of health technologies.

 

5. How are HTA assessments translated into reimbursement conditions in your country?

For the purposes of prior evaluation agreements and reimbursement matters, medicinal products must be subject to a pharmacoeconomic and pharmacotherapeutic evaluation.

 

6. Which are the evaluation criteria, processes or models and analyses framework used for HTA in your country?

The assessment or re-evaluation is subject to a pharmacotherapeutic and/or economic evaluation. The technical-scientific criteria for assessing the different health technologies are established in a regulation approved by Infarmed.

 

7. What is the methodology used in your country for HTA assessment?

HTA assessment aims to support the decision to use and finance health technologies in the NHS. This decision is based not only on the criteria of quality, safety, and efficacy but also on criteria of comparative economic effectiveness and efficiency, to optimize the use of available resources.

 

Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment, as referred below.

8. Which are the other decisions impacted by the assessed outcome in your country?

HTA assessment constitutes grounds to:

• Decide on the price, reimbursement, acquisition or installation of health technologies;
• Issue recommendations or decisions on the use of any health technology;
• Decide on the maintenance of the reimbursement or the acquisition, after prior evaluation of health technologies.

 

9. Does your HTA review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?

Infarmed may enter into protocols or contract health technology assessment experts, whether legal or natural persons, national or foreign, to conduct health technology assessments.

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1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link)

Yes. Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment. The recommendations can be consulted here.

 

2. Have local Authorities published guidelines surrounding value assessment dossiers? (If yes please add link)

Yes. Please refer to Chapter VI, question 1.

 

3. Have local authorities published official guidelines surrounding the submission of value assessment dossiers? (If yes please add a link)

Yes. Please refer to Chapter VI, question 1.

 

4. Describe the overall process of preparing and submitting a HTA dossier in your country.

The process starts with the submission of the application, followed by the pharmacotherapeutic evaluation and the economic evaluation, where comparability is made through price-comparison, cost-minimization, and economic evaluation studies. Then, negotiation takes place, considering therapeutic alternatives, budgetary impact, and affordability. Finally, the recommendations and decisions are made.

 

5. Describe the overall content of the HTA dossier in your country.

The HTA must contain technical information that demonstrates the medicinal product is safe, effective, and efficient for the claimed therapeutic indications.

 

6. Which are the questions to focus on when preparing a HTA dossier in your country?

Please refer to the previous question.

 

7. Which are the other strategic considerations to take into account when preparing a HTA dossier in your country?

There are several strategies that are worth following, namely:

• The search strategy should be reproducible, established in line with the framework and the goal of the evaluation;
• Literature selection should be based on explicit inclusion and exclusion criteria, using standardized and recognized methodologies:
• Ineligible studies should be listed, along with the justification why they were excluded and a flow chart summarizing this information;
• Every effort should be made to include all relevant evidence, regardless of language.

 

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1. In addition to the clinical data obtained through clinical studies please list the data required for:

a. Market approval

The data that must be submitted varies according to the type of medicinal product and the applicable procedure. In any case, general requirements for obtainment of a marketing authorization apply, the applicant having to submit data such as:

• General information of the medicinal product (proposed name, pharmaceutical form, quantitative and qualitative composition of all constituents, therapeutic indications, contraindications and adverse reactions, posology, method and route of administration, presentation and shelf life);
• Data concerning the manufacturing process and methods of the medicinal product;
• Description of the control methods employed by the manufacturer;
• Draft summary of product characteristics, product packaging mock-up, leaflet;
• Summary of the pharmacovigilance system,
• Risk management plan;
• Environmental risks report.

 

b. Pricing Decisions

For medicinal products subject to a medical prescription reimbursed by the Portuguese State or that are under a reimbursement request provided outpatient and at pharmacies, and the price of reimbursed medicinal products not subject to a medical prescription, the prices are established based on a comparison with the prices practiced in reference countries for the same medicinal product. Should the same medicinal product not be available in the reference countries, then the information shall relate to identical or essentially similar specialties of that product (generic medicinal products being excluded). Should identical or essentially similar specialties of that product not exist in the reference countries, then applicants may refer to those commercialized in their own country.

As for generic medicinal products, the pricing results from a comparison with a reference medicinal product, with the same dosage and pharmaceutical form, so applicants must submit data on said products and their prices.

For medicinal products subject to parallel import, applicants must submit data related to the prices practiced for the equivalent medicinal product subject to a marketing authorization in Portugal.

 

c. Reimbursement Decisions

Applicants must submit data on the therapeutic indications and other elements considered useful to the assessment of the process, namely technical-scientific information about the medicinal product that demonstrates its efficacy, safety and effectiveness for the therapeutic indications claimed as well as information about the pathology for which the medicinal product is intended, in order to demonstrate the therapeutic innovation or therapeutic equivalence of the product for the therapeutic indications claimed. Applicants may also be required to submit an economic evaluation study to support the economic advantage of the medicinal product, either based on a cost-minimization analysis or on a comparative price analysis, to be applied when claiming therapeutic equivalence to other products.

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1. Are there any Managed entry agreements in place in your country? (If so, please list them)

Yes. Infarmed can choose to enter into managed entry agreements (MEA) with marketing authorization holders to regulate the risk of expenditure on innovative medicinal products without concrete evidence of clinical benefit. There are no official public listings of the managed entry agreements currently in place.

 

1.1. For each Individual Managed entry Agreement, describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it.

The rationale behind entering into MEAs is to try to reduce the risks associated with the uncertainty of the introduction of new medicinal products (or approved therapeutic indications) in the NHS, and ultimately ensuring patient access to innovative therapies without compromising the sustainability of the NHS. MEAs can facilitate reimbursement decisions of certain medicinal products with little evidence of clinical benefit, which are often delayed due to the lack of information on the effectiveness of the medicinal product, by implementing satisfactory risk sharing solutions.

Infarmed celebrates financially based MEAs (like price-volume agreement, where marketing authorization holders must reimburse the NHS if expenditure with the medicinal product exceeds a previously agreed upon cap), performance-based MEAs (like coverage with evidence development agreements, where the reimbursement conditions may be re-evaluated if certain outcomes are achieved), or a combination of both types of MEAs. There is also the possibility of creating patient access schemes (PAPs), for medicinal products with or without an approved marketing authorization, under which pharmaceutical companies ensure access to the medicinal product for free for a limited time period.

 

2. When should this Managed Entry Agreement be considered?

In cases of medicinal products which do not have a recognized clinical benefit, to allow the use and patient access to innovative medicinal products. Patient access schemes are also created to enable access to medicinal products which do not even have an approved marketing authorization, when no other satisfactory therapeutic alternatives have been authorized in order to treat, prevent or diagnose rare or serious/extremely debilitating diseases. They can also be considered to enable access for a specific patient in cases where the marketing authorization of the medicinal product has been approved, but the negotiation of the reimbursement conditions has not been finalized.

In Portugal, MEAs have been used in cases of innovative therapeutic indications for medicinal products with multiple indications and in innovative combinations of medicinal products, where the effectiveness of the medicinal product is unknown or uncertain, mostly in the oncology area and in relation to Hepatitis C.

 

3. Which are the specific requirements to implement the Managed Entry Agreement.

There is no legal regime that regulates MEAs in general, it only being foreseen in Decree-Law no. 97/2015, of June 1 that Infarmed and the marketing authorization holders may include risk sharing mechanisms when negotiating the reimbursement conditions of medicinal products. This is carried out on a case-by-case basis.

For patient access schemes, Deliberation no. 80/CD/2017, of October 24 of Infarmed, as amended lays out the requirements to create the so-called early access programmes. Without prejudice of other formal/technical requirements, for medicinal products without an approved marketing authorization, the applicant must demonstrate the efficacy and safety of use of the medicinal product based on the results of previous clinical trials. As for medicinal products with an approved marketing authorization but without a reimbursement decision, there cannot have been a decision rejecting the reimbursement procedure, and the applicant must present the justification for the use of the medicinal product under the early access program.

 

4. What is the potential impact on the product uptake?

As noted above, MEAs have the potential to accelerate the approval of reimbursement conditions for certain medicinal products with little evidence on their effectiveness and clinical benefits, and thereby facilitate patient access to innovative therapies. Thus, it is a natural consequence that product uptake increases as new treatment options are made available to patients.

 

5. What are the potential challenges associated with this Managed Entry Agreement?

There are many challenges related to the implementation of MEAs, and they vary depending on their nature and the scheme they are based upon.

One of the main challenges, specifically in outcome based MEAs, is the monitoring of the execution of the agreements. These agreements are typically dependent upon the collection and exchange of information, which means that the parties are required to collaborate and make information available to each other by reporting on the use of medicinal products. Requiring compliance with reporting obligations may prove to be difficult.

Parallel to this, data protection concerns may be raised because MEAs depend on the exchange of sensitive patient data between healthcare establishments, pharmaceutical companies and the regulatory authorities.

Another significant issue that may be raised is the difficulty in agreeing upon performance indicators to determine when the medicinal product is proving to be effective, to which is then later added the challenge of evaluating and determining whether said performance indicators have or have not been met.

In addition to the above, the fact that there are no well-established standards or good practices, nor any defined legal/regulatory requirements, for the celebration of MEAs determines that there is little cohesiveness, stability and recognized reputability in the use of these solutions.

Lastly, and in a more general note, the fact that there is a lack of official information published on MEAs by the competent regulatory authorities hinders the development of these solutions.

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1. Which are the main actors involved in public procurement and tendering?

Within the health sector, public procurement and tendering involve mostly the participation of entities pertaining to the NHS, namely public companies who manage public healthcare facilities, clinics, hospitals, investigational sites.

 

2. What are the main characteristics of the public procurement and tendering system?

The Portuguese public procurement and tendering system follows the European Union rules, according to which public entities must launch public procurement procedures in order to acquire goods, works or services from market operators. These procedures must follow the public interest and ensure competition, publicity and transparency.

There are several types of procedures that can be followed by public entities, and these depend mainly on the goods, works or services to be acquired and their cost. In the health and pharmaceutical sector, the most common procedures to be followed are public tenders, where several entities may present a proposal, and direct awards, where a specific entity is invited to submit a proposal.

One specificity of the health and pharmaceutical sector is the centralized purchasing of products, through SPMS – Serviços Partilhados do Ministério da Saúde, which manages and centralizes public procurement procedures for some entities of the National Health Service.

Considering the usual practices of the pharmaceutical sector in regards donations to healthcare facilities, it is worth noting that Portuguese public procurement rules may prevent a company (including its affiliates) from participating in direct awards and prior consultation procedures when such company has provided free of charge goods, services or works to the public entity which is inviting the company to present a proposal.

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1. Has an essential or priority drug list been published in your country? (If so provide the link)

Portuguese health authorities have not approved an “essential medicines list”. However, there’s a list in force in Portugal, approved and updated by National Pharmacy and Therapeutics Commission (CNFT), a technical commission which works as an advisory body of Infarmed, which incorporates several medicinal products deemed essential for the functioning of hospitals. The list is the National Formulary of Medicinal Products (FNM – Formulário Nacional de Medicamentos) and is available here.

 

2. If so what is the impact/consequences of a drug being published on the EDL/PDL:

a. In terms of market approval

These is no impact in terms of the market approval process.

 

b. In terms of reimbursement

There is no impact in terms of reimbursement.

 

c. In terms of pricing

There is no impact in terms of pricing.

 

d. In terms of value assessment and pharmacoeconomic requirements

There is no impact in terms of value assessment and pharmacoeconomic requirements.

 

3. Do value assessment and pharmacoeconomic data play a role in terms of access to the list?

Yes. The inclusion of a medicinal product in the National Formulary of Medicinal Products, amongst other criteria, is based the existence of therapeutic alternatives, as well as the pharmacoeconomic evaluation, in order to select, amongst the various therapeutic options available, the one that better ensures the rational use of medicinal products by the National Health Service.

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1. What is the definition of an orphan drug in your country?

A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (i) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons (5 in 10 000) in the community when the application is made, or (ii) that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment. Alternatively, the sponsor can also establish that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

 

2. Describe the pricing process of orphan drugs in your country.

Orphan drugs follow the general rules on pricing of medicinal products. Therefore, please refer to the previous answers.

3. Describe the reimbursement process of orphan drugs in your country.

Orphan drugs follow the general rules on reimbursement of medicinal products. Therefore, please refer to the previous answers.

 

4. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of orphan drugs differ from that of other drugs?

No.