Legal & Regulatory > Spain > Essential Drug List

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

Yes. Three types of lists have been published by the AEMPS:

• “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system.
• “Critical medicinal products”: a subgroup of essential medicinal products for which there should never be supply problems in the health system.
• “Strategic medicinal products”: a subgroup of critical medicinal products for which additional measures, whether regulatory, economic or otherwise, are considered necessary to ensure their maintenance in the market both because of their need for basic health care and because of the vulnerability of their supply chain.

Such lists are published at the AEMPS’s official website.[1]

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

a. In terms of market approval

Three main consequences are worth mentioning in this area.

First, AEMPS has put in place the necessary mechanisms to speed up the administrative procedures and the evaluation of changes to the MA of these medicinal products. To this end, it has established shorter deadlines for the validation of applications and a prioritized evaluation of the variations requested.

Second, AEMPS offers scientific and regulatory advice to laboratories. This advice can be provided throughout the application process or facilitating the submission of the registration dossier. The evaluation of authorization applications for medicinal products submitted through the national route will be expedited as a matter of preference in order to favor the availability of these medicinal products on the market in the shortest possible time.

Third, the AEMPS will prioritize the granting of Spanish slots as a reference member state (RMS) for authorization applications through European procedures in order to favor the internationalization of these strategic medicinal products.

b. In terms of reimbursement

The inclusion of a product in such lists does not have a direct impact on reimbursement decisions. Being included in such lists, however, may facilitate product’s compliance with art. 92 of Royal Legislative Decree 1/2015 and, therefore, may indirectly facilitate reimbursement. Please refer to Question 1, Section III above.

c. In terms of pricing

Essential products may have preferential treatment in the context of reference pricing. As discussed, the inclusion of a medicinal product into a reference group implies the reduction of the PVL of the originator per DDD to the level of the PVL per DDD of the biosimilar/generic. Such reduction may be effective immediately (general rule) or gradually during several years in accordance with specific rules contemplated in art. 4 of Royal Decree 177/2014 (“Weighted Average”). Under the Weighted Average regime, the price of the original product is gradually lowered year by year in a staircase fashion.

The preferential treatment of essential medicinal products consists of freezing their price if they are subject to the “Weighted average” regime. For such special regime to apply, companies must demonstrate that the price freeze is necessary to ensure the availability of the medicinal product and that the essential medicinal product has no reimbursed alternatives.

d. In terms of value assessment and pharmacoeconomic requirements

As far as we are aware, being in the abovementioned lists does not have any direct impact on value assessments or pharmacoeconomic requirements. Indirectly, it may have some impact to the extent that being in such lists necessarily means that the product is considered critical and indispensable for the proper functioning of the system, which implicitly implies a recognition of value.

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

No. Inclusion in the mentioned lists is based on criticality and vulnerability criteria, not economic assessments.

[1] Accessible at: https://www.aemps.gob.es/medicamentos-de-uso-humano/medicamentos-estrategicos/