By Pharmaceutical companies are on a war footing as the Commission proposes to shorten the duration of patents for some medicines so that new companies can enter the pharmaceutical market, to address the growing shortage of medicines, insufficient research on new antimicrobial and to lower selling prices of pharmaceutical products. In addition, the Commission justifies the new legislative proposals by saying that, unlike in U.S., when European citizens move to the continent, they do not always find the same prescribed medicines at home. Not to mention the shortage of medicines for rare diseases. But the decision to use the ax against pharmaceutical companies could be detrimental also to smaller ones, not being able to compete with the Big Pharma.
Brussels, 2 May 2023
On 26 April 2023, the Commission has proposed a new legislation to improve the regulation of medicines in the EU. This is in the framework of the new european Pharmaceutical Strategy, that it should enhance the availability and affordability of medicines while promoting innovation and sustainability in the industry. But on patents it could cause a serious earthquake in an economic sector that, despite the huge profits of some pharmaceutical companies for the production of Covid19 vaccines, is already suffering.
The Commission strategy
The strategy has four key pillars.
The first pillar focuses on ensuring access to affordable medicines for patients, particularly in low and middle-income countries.
The second pillar aims to support innovation in the pharmaceutical industry, particularly in the areas of rare diseases and antimicrobial resistance.
The third pillar of the strategy focuses on strengthening the EU’s regulatory framework for medicines, particularly in the areas of clinical trials and pharmacovigilance. This includes improving the transparency of clinical trial data and increasing cooperation between national regulatory authorities.
Finally, the fourth pillar of the strategy aims to promote a more sustainable pharmaceutical industry, particularly in terms of reducing the environmental impact of pharmaceutical production and reducing the reliance on non-renewable resources.
The new proposed Legislation
The proposed legislation, one Regulation, a Directive and a Council Recommendation, has been welcomed by many stakeholders in the industry, including patient groups, healthcare professionals and pharmaceutical companies.
It foreseen not only a revision on patent protection lenght for some medicines or for market structure, but also a kind of mandatory patent license that allows a government to authorize the use of a patent/invention without the consent of the patent owner: it would complement existing tools to manage crises.
However, critics have raised concerns about the potential impact on innovation and competition in the sector and Big Pharma are concerned.
The new rules are expected to be discussed and finalised in the coming months, when the European Parliament and the Council of the EU are expected to debate and decide on the new proposals.
All eyes are now on the 30 members of the European Parliament’s Health Sub-Committee who will have to appoint a Rapporteur. And the shadow rapporteurs by political Groups. 7 golden men who will decide how the Strasbourg Chamber should vote on the controversial proposal. There will certainly be room for a compromise solution and also for a commitment to invest more in research and innovation.
Read more on the content of the proposal…
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