No agreement on access to medicines

The health ministers of the European Union had to show their colours at their meeting in Luxembourg on 21 June. In a public agenda item right at the start of the Council meeting, they discussed the design of the incentive systems as part of the pharmaceutical package proposed by the European Commission in April 2023. The focus was on the redesign of the incentive system for medicinal products proposed by the European Commission and the options for creating incentives through data protection and market protection. Both rights protect the exclusive marketing by the manufacturer and are intended to ensure the amortisation of its investment in the new medicinal product. They thus provide an incentive for the development of further medicinal products.

Around twenty Council working groups have met on the reform so far. The progress report and the background paper make it clear how difficult it is to find a common line among the member states. The aim of the discussion is to define the framework within which a compromise on new regulations on regulatory data protection and market protection is possible and to provide the Council working groups with guidance.

As a reminder

In its proposal for a regulation and directive on the pharmaceutical reform, the European Commission has proposed the introduction of a differentiated incentive system for pharmaceutical manufacturers. The regulatory protection periods are linked to conditions: marketing in all 27 EU member states, the fulfilment of unmet needs, the performance of comparative clinical trials and the identification of further indications for a medicinal product. Overall, the proposal provides for a two-year reduction in the protection period of a medicinal product's dossier in order to enable the earlier market launch of more affordable generics and biosimilars. However, it is not possible to speak of a general shortening of the protection periods, because if a medicinal product fulfils all the conditions, exclusivity protection can last for a maximum of twelve years. Today it is eleven years. Standard market exclusivity for orphan medicinal products will also be reduced by one year from ten to nine years. In total, however, protection periods of a maximum of 13 years instead of the current ten years can be granted if additional conditions are also met here.

In its position, the European Parliament has called for the introduction of a minimum period of seven and a half years for regulatory data protection and two years of market protection following authorisation. They also want to adjust the staggering of incentives (see also DSV News).

The discussion

Although the discussion in the Council provided some orientation, a common line was not recognisable. Instead, two camps emerged. On the one hand, mainly Eastern European Member States such as the Czech Republic, Latvia, Malta and Poland, which have difficulties in obtaining even low-cost medicines such as generics, and on the other hand, industry-friendly Member States that are more "attractive" to pharmaceutical manufacturers such as France, Germany and Denmark. While some were in favour of shortening data protection to six years, others called for no reduction and for the "status quo" of eight years to be maintained. In principle, however, most ministers were in favour of modulating the incentive system, as proposed by the Commission, provided that the legal framework is clear and predictable and takes account of the need for innovation.

Another discussion concerned access to medicinal products. The Commission proposed that pharmaceutical manufacturers receive an additional two years of market exclusivity if they market the medicinal product in all 27 EU Member States. In the orientation debate, this supply obligation continued to be supported by some Member States. Others, including Germany, favour an option decoupled from the incentives of additional market exclusivity, whereby manufacturers are obliged to negotiate with the Member States that have previously submitted an application for pricing and reimbursement.

The Hungarian Council Presidency will now continue the negotiations. There is still a long way to go to reach a common line in the Council.