First yes to EU drug reform, the no from Italy and the companies is not enough

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The EU drug reform overcomes the first obstacle. Almost a year after its presentation by the EU Commission during which there was no lack of strong discussions, including the clear opposition of the Italian Government which joined the protests of companies in the sector in which Italy is the leader in Europe, it has arrived the first green disc of the European Parliament. The ball is now in the European Council’s court for the continuation of the process, even if the dossier will now be taken up again in the next mandate after the European elections in June with all the uncertainties involved.

A package of measures that has been awaited for 20 years

The green light from the chamber in the plenary session came to a package of measures that have been awaited for 20 years – a directive and a regulation – which intervenes on various fronts of the pharmaceuticals planet: from the issue of the shortage of medicines which has worsened after the pandemic to incentives for the production of increasingly important antibiotics, from digital information leaflets in all languages ​​(the so-called “leaflets”) to orphan medicines up to the hottest topic, that of the regulatory protection of drug data. Indeed, among the most contested points of this reform is precisely that of the reduction of data protection which for companies is one of the cornerstones of intellectual property protection (preventing other companies from being able to access drug data) and probably represents the main siren that – together with incentives for research – attracts large investments from Big Pharma. Discovering and developing a new medicine costs a lot and therefore a longer exclusivity on the market is an important incentive.

The most controversial rules

The text of the reform presented in April 2023 by the EU Commission reduced this data protection period from the current 8 years to 6 years, now the new text amended already in the Environment and Health Committee and the result of a compromise by the EU Commission brings this term to 7 and a half years plus two years of market protection (period during which, for example, generic medicines cannot be sold). This compromise was confirmed by the MEPs in the chamber with a large majority and on which there has already been an outcry from pharmaceutical companies who reject the reform as worsening Europe’s competitiveness, also criticizing the “bureaucratic” conditions which allow you to extend this data protection. The reform in fact provides for the possibility of extending the “protection” to a further 12 months if the drug responds to unmet medical needs, a further 6 months if it involves the development of comparative clinical studies and a further 6 months if a portion of the research investments are carried out in Europe. An additional year of market exclusivity is recognized for an additional therapeutic indication that brings significant clinical benefits compared to existing therapies.

The rejection of Italian and European companies

«It is a black day for Europe and bad news for the right to health of European citizens as well as a further step towards making the supply chain of European pharmaceutical companies lose even more competitiveness in carrying out research and innovation compared to our foreign competitors towards which we have already lost a lot of ground”, underlines the president of Farmindustria Marcello Cattani. Which now asks the new European institutions that will emerge from the next vote in June “to review the direction of the reform and focus on a vision that truly defends the European industry on crucial issues of patent protection such as data protection and market exclusivity”. Also in the same vein Nathalie Molldirector general of the association of European pharmaceutical companies (Efpia) for whom «it is difficult to understand how reducing incentives for research, development and production of new drugs and vaccines could be in the best interest of Europe or European patients, particularly at a time when Europe recognizes that it must increase competitiveness to compete for global investment with ambitious nations such as the United States and China.”

The contrary position of the Italian Government

Already in the early stages of the European reform proposal the Italian Government through the Minister for European Affairs Raffaele Fitto had sent a very critical official document to the EU Commission underlining the need to “avoid the risk of weakening the protection of intellectual property”. A concept reiterated by the senator Francesco Zaffini (Fdi), president of the Criticism too Maria Angela DanziMEP of the 5 Star Movement but for the opposite reason because she is not satisfied “with the increase in regulatory data protection and because the EMA governance reform has been watered down”. Stefano Collatina president of Egualia (producers of generics) instead defends “the steps forward that have been made” and that they can still be made “in the next phases of the legislative procedure”.