A few weeks ago, our colleague Claudia Gonzalo wrote on this same platform about the proposal for the review of pharmaceutical laws presented by the European Commission. This proposal, according to the Commission itself, aims to create a true “European Health Union” and seeks to move what are already known as triple A: access, availability and affordability.
Jordi Faus is a lawyer-partner at Faus & Moliner.
Joan Carles Bailach is a lawyer in Faus & Moliner.
This week we participated in the EU Pharmaceutical Law Forum in Brussels, where the most important developments in this proposal were discussed. Among the issues that were discussed, he highlighted the breach of the rules of the period of protection of data for commercial drugs. The Commission proposes to impose the longest possible protection period if certain conditions are met, including that the product is available in the 27 Member States within a maximum period of 2 years from the granting of the marketing licence. The words of Florian Schmidt (DG Santé), on the establishment of proposals that promote universal access in the European Union, to achieve approved medicines, the long-awaited single market, the health of the European Union.
The ending couldn’t be more laudable, but the problem has a problem. Reaching this milestone, the market of the product in 27 Member States within 2 years does not depend on the will of the owner of the drug. There may be cases where the licensee does not have the capacity, structure or interest to market the product in all Member States. In such cases, a longer protection period may be attractive.
But how to deal with several cases in which the position of the product in the market depends on the national health decision-making system, to be included in the list of benefits, and to reach a public agreement? The incentive condition of two years of regulatory protection to the fact that the price and compensation system concludes the decision accepted by both parties and when the market is made, puts the companies in a very complicated situation, especially for the purpose of making. long judgment EFPIA proposes to establish, as one condition to achieve this 2-year period, that the pharmaceutical company has yielded to the price and reimbursement requests obtained in the 27 Member States in the first two years after the CA; to which the Commission responds that this situation does not serve to improve the accessibility of new medicines in the European Union.
For more than 30 years, Europe has managed to approve the transparency directive, which imposes certain obligations on member states in relation to drug systems. The discussion of the current proposals forces us to recognize that beyond what is provided for in directive 89/105, it is very difficult, the ability to influence the European Union in this area is limited, but who knows, in 2020 the purchase of the Vaccine against Covid-19 has been carried out under equal conditions in the EU, one approach reaching the pandemic.