AseBio Says Proposed EU Pharmaceutical Legislation Puts Biotech Innovation at Risk

EuropaBio, an association that represents the biotechnology industry in Europe and of which AseBio is a part, has published the results of a study that warns of the negative impact of the Commission’s draft general pharmaceutical legislation (GPL) European in terms of innovation in the biotechnology sector, especially in the case of small companies.

It can especially affect countries like Spain, where 96% of biotechnology companies are SMEs and microSMEs. A significant detriment at the critical moment in which we find ourselves immersed: a global race to improve patient safety in healthcare and maintain a competitive position.

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AseBio says general pharmaceutical legislation sends a worrying message to investors

In this regard, they remember that the biotechnology sector is characterized by operating in very complex and regulated markets. In this sense, the photograph we observe reveals a high risk and long development periods until disruptive ideas are transformed into tangible benefits for patients. “A scenario in which small companies are presented as the main vehicle of innovation in an environment in which collaboration between companies of all sizes is crucial,” he says.

The study reports that general pharmaceutical legislation sends a worrying message to investors and innovators, which is that “the European Union has relegated innovation in the field of health . ” In this sense, he criticizes that “the reduction of base incentives stands as a barrier to biotechnology programs in early stages in all companies, regardless of their size.” 

A situation that, they added, “ greatly affects” small innovative companies, endangering the powerful research base that Europe currently has.

“A scenario in which small companies are presented as the main vehicle of innovation in an environment in which collaboration between companies of all sizes is crucial”

The path laid out by general pharmaceutical legislation, according to the study’s conclusions, makes it less likely to achieve objectives related to, for example, rare diseases, as restrictions and reductions in incentives in turn affect clinical trials and the therapeutic options that European patients have at their disposal.

The proposed reductions in incentives form part of the foundations of collaboration, essential for drug development. The study suggests that this reduction in incentives will lower the demand by the most mature companies for technologies in early stages and, therefore, will negatively affect the collaborations between them and the most innovative companies, significantly harming smaller companies. .

The draft general pharmaceutical legislation should encourage biotechnological innovation in the European Union

In his opinion, the draft general pharmaceutical legislation should encourage biotechnological innovation in the European Union. Furthermore, they consider that the positive changes introduced by the general pharmaceutical legislation do not offset the negative impact of the rest of the proposals or consider that they are ineffective, especially from the point of view of smaller companies.

In this sense, the research argues that Europe advances and succeeds when it commits to promoting innovation. Contributing to the increase of grassroots incentives in the biotechnology sector will help more companies obtain the necessary investment to tackle innovative projects in early phases.

“General pharmaceutical legislation must be a central pillar for the European Union’s strategy on resilience in healthcare through global competitiveness in biotechnology”

“General pharmaceutical legislation must be a central pillar for the European Union’s strategy on resilience in healthcare through global competitiveness in biotechnology. It must empower European innovators, especially small and growing biotech companies, and reprioritize the crucial role of our sector ,” defends EuropaBio CEO Claire Skentelbery.

“Instead of reducing we must increase baseline incentives, eliminate the seven-year limit for Orphan Designation, increase market exclusivity for orphan drugs and avoid definitions that restrict progress against rare diseases in Europe. This will allow Europe to grow as a global center of research excellence and be the cradle of innovative medicines, with patients, economies and healthcare systems as beneficiaries,” he concluded.

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(Featured image by NakNakNak via Pixabay)

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First published in iSanidad. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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