Legal & Regulatory > Spain > Post Market-Approval Processes and Regulations

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

Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed.

To determine whether a medicinal product is reimbursed or not, the DGCC/CIPM must take into account the following criteria (art. 92 and 94 of Royal Legislative Decree 1/2015):

1. the seriousness, duration and sequels of the pathologies for which the product is approved;
2. the needs of special groups of people;
3. the therapeutic and social utility of the product as well as its incremental clinical benefit, taking into account its cost and effectiveness;
4. the need to limit and rationalise public pharmaceutical expenditure and the impact of the medicinal product on the NHS;
5. the existence of medicines already available and the existence of other alternatives for the same illnesses, which have a lower price;
6. budget impact and cost-effective analysis;
7. The contribution of the product to Spain’s gross domestic product;
8. the degree of innovation of the product: whether it provides an indisputable therapeutic advance for altering the course of an illness or easing the course of such illness; and its results or contribution to the NHS;
9. The return mechanisms that may be proposed by the MAH (discounts, price reviews). This is the result of the increasing relevance that risk-sharing schemes are currently having in Spanish practice; many companies, especially for high-budgetary-impact products, are required to offer specific arrangements to obtain reimbursement.

From a procedural standpoint, the typical P&R Procedure (there may be particularities/changes on a case-by-case basis) incorporates the following phases: (i) initiation: the P&R Proceeding starts ex-officio; the DGCC shall send a letter to the MAH or to its local representative (“LR”), informing it that the process has begun and granting the MAH a period between 10 and 15 working days to make any submission it deems convenient on the reimbursement of the product, (ii) negotiation between the MAH/LR and the DGCC, and preparation by the DGCC of a report for the CIPM in which the DGCC performs a therapeutic (and sometimes economic) evaluation of the new drug/new indication (this report is commonly referred to as the “Associate Report for the CIPM” or “Associate Report”), (iii) evaluation of the new medicinal product/new indication by the CIPM, (iv) issuance by the DGCC of a draft resolution on the reimbursement/non reimbursement of the new medicinal product/new indication as resolved by the CIPM, (iv) submission of allegations by the MAH/LR (if any), (v) assessment of the allegations by the CIPM/DGCC (if any) and (vi) final ruling of the DGCC.

Under the law, the whole P&R Proceeding may take up to 180 days. However, authorities usually request additional information, and these requests may stop the clock on the procedure. In practice, companies may well expect the reimbursement approval to run for a minimum of six months. Occasionally, procedures have taken longer.

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

Theoretically, generics and biosimilar drugs must go through the same P&R Procedure explained in Q1 (Section III) above. However, in practice, what usually happens is that such products go through a sort of “simplified” P&R Procedure which, in essence, means that generics/biosimilar products are reimbursed with an approximate 40% (generics) or 20-30% (biosimilars) discount with respect the originator.

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

Please refer to Q1 (Section III) above.

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

Please refer to Q2 (Section III) above.

5. Are there any other special processes to be considered for certain types of drugs?

Non-industrially manufactured advanced therapy medicinal products (“ATMPs”) are subject to a special P&R Procedure.

In October 2019, the CISNS issued an agreement on the general conditions for planning, coordination, contracting, procurement and supply of ATMPs for the publicly owned structures and services integrated in the NHS (the “2019 Agreement”).

In the 2019 Agreement, the CISNS confirmed that for the reimbursement of medicinal products, their inclusion in the pharmaceutical provision of the NHS is necessary because this is contemplated in art. 92.1 of Royal Legislative Decree 1/2015. However, in contrast to industrially manufactured medicinal products where the DGCC and CIPM are competent (see Q5 Section II), the 2019 Agreement determined that CISNS is the competent body to decide on the reimbursement of non-industrially manufactured ATMPs.

The 2019 Agreement was based on the opinion of the State Attorney who relied on art. 91.6 of Royal Legislative Decree 1/2015 that expressly states that “[T]he Interterritorial Council of the National Health System may agree on the general conditions for planning, coordination, contracting, procurement and supply of medicines and medical devices of the publicly owned structures and services integrated in the National Health System”.