The European Parliament’s Committee on Public Health (SANT) and Committee on Industry, Research and Energy (ITRE) have published the amendments, dated 14 and 15 July, to the draft report on the proposal for a regulation on biotechnologies (see EUROPE 13899/17), led by Vytenis Povilas Andriukaitis (S&D, Lithuanian) for the SANT Committee and Wouter Beke (EPP, Belgian) for the ITRE Committee. Nearly 2,400 amendments had been tabled by the submission deadline of 7 July.
The points raised concern the balance between support for innovation, access to treatments, environmental protection, and the safeguards surrounding clinical trials.
Protection of intellectual property. Article 27 of the European Commission proposal provides for granting an additional 12 months of supplementary protection certificate to so-called best-in-class biotechnological medicines, in order to encourage the development of new therapies. Anthony Smith (The Left, French), Anja Hazekamp (The Left, Dutch), Marina Mesure (The Left, French), and Emma Fourreau (The Left, French) are calling for its complete deletion, because the available studies allegedly do not show that an extension of the protection period encourages investment. Marie Toussaint (Greens/EFA, French) and Ville Niinistö (Greens/EFA, Finnish) support the same objective.
Moreover, several MEPs have chosen to maintain the extension, but make it harder to obtain.
Thus, Adam Jarubas (EPP, Polish) wants to reserve it for active substances whose novelty has been verified by the European Medicines Agency. Vytenis Povilas Andriukaitis, for his part, requires clinical trials conducted in more than five Member States, counter to more than two in the Commission proposal.
In addition, the objectives of the future regulation are also being questioned. In Article 1, Stine Bosse (Renew Europe, Danish) proposes adding to the aims of the text improved outcomes for patients, addressing unmet medical needs, and strengthening the resilience of health systems. The Greens/EFA Group wants to include equitable and affordable access to innovations.
High-impact strategic projects. Christine Anderson (ESN, German) is also calling for the deletion of Article 4, which creates this mechanism intended to accelerate certain projects deemed strategic. In addition, two amendments seek to delete, in recital 30, the possibility of allowing these projects to take precedence over certain interests linked to nature protection.
The amendments: https://aeur.eu/f/n0p ; https://aeur.eu/f/n0q ; https://aeur.eu/f/n0r ; https://aeur.eu/f/n0s ; https://aeur.eu/f/n0t ; https://aeur.eu/f/n0u ; https://aeur.eu/f/n0v ; https://aeur.eu/f/n0w ; https://aeur.eu/f/n0x (Original version in French by Nithya Paquiry)