The Danish Presidency of the EU Council stated on Tuesday 2 December, during the ‘Employment, Social Policy, Health and Consumer Affairs Council’ (EPSCO), that it hoped the December 10 meeting between the Council and European Parliament would lead to an agreement on the proposals to update pharmaceutical legislation.
Sophie Løhde, Danish minister for health, pointed out that there have already been two rounds of Council/European Parliament negotiations and that progress has been made on sensitive aspects of the proposals, such as antimicrobial resistance, protection periods, the ‘Bolar exemption’ and security of supply (see EUROPE 13750/19). Her objective remains to reach a political agreement before the end of the Danish Presidency, striking a balance between patient access and innovation.
European Commissioner for Health and Animal Welfare Olivér Várhelyi said that the reform could “redefine the European pharmaceutical landscape for decades to come”. In his view, the package will improve the availability of innovative therapies, develop new antimicrobials and prevent shortages. He noted that negotiations are now entering the home stretch.
The Czech Republic advocated for a modulation of incentives for the industry and the retention of national registration authorities. It finds it difficult to accept a final agreement that deviates from the Council’s mandate.
Belgium has said it is open to an agreement but is concerned about the provisions on exclusivity, which account for almost 30% of national expenditure.
France will continue to ensure the legal robustness of the ‘Bolar exemption’ and the right of patients to vote on the Committee for Medicinal Products for Human Use.
Germany has requested the ‘Bolar exemption’ be extended, as have Spain, Poland and Hungary.
Poland advocated for a maximum protection period of 11 years and the introduction of a mechanism to combat unequal access to medicines in the EU. Hungary is also opposed to any extension beyond 11 years of protection. (Original version in French by Lionel Changeur)