2023-04-27 12:55:00
The European Commission has unveiled the outlines of the future development of pharmaceutical legislation, also known as the “pharmaceutical package”. A substantial revision of the long-awaited 2004 directive. It must be said that this reform aims “to strike the right balance between promoting innovation and ensuring patient access to affordable medicines across the EU”underlined Margaritis Schinas, Vice-President of the European Commission.
A note of intent once morest which the Commission issues a series of recommendations (see also our box) to varying degrees appreciated by the companies concerned. The European Federation of Pharmaceutical Industries and Associations, EFPIA, criticized the project, going so far as to mention “a risk of sabotage of the life sciences industry in Europe”.
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At the heart of the critics, the flagship incentive measure, intended to introduce a variable duration of protection for medicines, according to objectives of innovation and access to all EU member countries.
Varying terms of protection for patents
Concretely, laboratories marketing an innovative medicine will benefit from a minimum regulatory protection of eight years, including six years of protection on regulatory data and two years of protection on the market, compared to eight years and two years currently. In return, this period may be extended to a maximum of twelve years, compared to eleven years today.
According to what criteria? This is where the proposed system takes a complex turn. A bonus of two additional years will be granted to a drug launched in all Member States. If it meets an unmet medical need, + 6 months, and once more + 6 months if comparative clinical trials will be conducted. If the drug can treat other diseases, an additional year will be provided to reward the laboratory.
A progressive system difficult to apply, according to the EFPIA. “The approach adopted in this legislation, [qui consiste à, N.D.L.R.] (to) penalize innovation if a treatment is not available in all Member States is fundamentally flawed and represents an impossible target for companies”criticized Nathalie Moll, director general of the EFPIA.
A project still far from being adopted
While the announcement of the project had been postponed several times, provoking the anger of MEPs seeing it as an embarrassment to the industry, the hostile reaction of the drug companies suggests intense negotiations. “In the months to come, we will have to work with the members of the European Parliament, the Council and the other stakeholders (…), if changes are not made, the legacy of this Commission will have been to make ‘Europe a simple consumer of medical innovation from other continents and to make European patients wait longer than ever for access to the latest innovations’, tackle Nathalie Moll. The Commission’s proposals will now continue on their way by being sent to the European Parliament and the Council.
Reduction of delays, reform of the EMA, new antibiotics, shortages… The other projects of the reform
Beyond the issue of patents, the reform introduces a series of measures aimed at shortening the time to market. The European Medicines Agency (or EMA) will now have 180 days to make its assessment instead of the current 210 days. For the marketing authorization, following consulting the EMA, the Commission will also have a reduced period, going from 67 to 46 days. A shortening made possible by a simplification of procedures and by a reorganization of the EMA. The agency will see its organization simplified to a committee for medicinal products for human use and a safety committee. Exit therefore the committee for orphan medicinal products, the pediatric committee and the committee for advanced therapy medicinal products, which are set to disappear. The aim is thus to let “increased support for the two remaining committees” and free “scientific resources to strengthen support for developers”, before permission requests. On this point, the Commission wishes to set up ” sandboxes » regulations to test new approaches and also pleads for the generalization of exchanges and transmission of files by electronic means.
Another major project is the fight once morest antibiotic resistance. The European Commission wishes to promote the development of new antibiotics, a market in which few laboratories are positioned today. The main measure involves a system of “coupons” (vouchers), which will give an additional year of rights for laboratories developing new antibiotics. These coupons can be resold and thus provide additional income to businesses. A mechanism close to that can exist in the United States with the “priority review vouchers” of the FDA, which gives priority access to the agency and are the subject of sometimes lucrative resales between laboratories On this point, as on the various still vague proposals around drug shortages, details will be awaited to fix the terms.
Finally, this reform proposal does not directly address the issue of relocation. On these subjects, the Commission refers to the PIIEC Santé, still under development, to the “Fab UE” manufacturing project intended to mobilize a network of vaccine producers in the EU as well as to the work of HERA, equivalent of the American BARDA, intended to better prepare Europe in the event of a new health crisis.
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