Diverging positions on the draft regulation and the draft directive

CC – 10/2023

Some six months after the publication of the draft legislation on EU pharmaceutical reform, Pernille Weiss (EPP, DK) and Tiemo Wölken (S&D, DE) have published their draft reports. The two documents on the draft regulationand the draft directive already give an idea of how difficult the negotiations in the European Parliament on the dossier will be, as the rapporteurs' points of view are very different. The draft report by Pernille Weiss (EPP, DK) on the draft directive is very industry-friendly, while the draft report by Tiemo Wölken (S&D, DE) on the proposed regulation seems to be more balanced.

Vouchers out – Set-up of a new European Medicines Facility

The proposed amendments in the area of antimicrobial resistance are welcome. The transferable market exclusivity vouchers ("vouchers") are cancelled. In the view of the rapporteur Wölken, they also represent an indirect and non-transparent form of pricing, causing unpredictable costs for national health budgets and delaying the market launch of generics to the detriment of patients. The German Social Insurance (DSV) had also spoken out against the vouchers. Instead, Wölken proposes the introduction of a new EU authority 'European Medicines Facility' (EMF). The EMF should identify specific purpose-driven research and development projects focusing on health priorities in the public interest at Union level, especially where the private sector is not driving research and development.

Further proposed amendments, which also correspond to the DSV position are the strengthening of evidence collection in the authorisation procedures, the deletion of the regulatory sandbox and the stricter differentiation of market exclusivity for orphan drugs.

Extension of document protection – No EU27 access

From the point of view of the payers, the proposal by rapporteur Pernille Weiss to extend the document protection is not welcome. Instead of six years, as proposed by the European Commission, Weiss is in favour of document protection for nine years. As a result, competition from cheaper generics and biosimilars would start later. This leads to higher pharmaceutical prices and would place a greater financial burden on the health insurance systems in the Member States. In addition, Weiss is scrapping the European Commission's staggered incentive system by rewarding market access for medicines in all 27 EU Member States with data protection. Instead, Member States should be able to independently demand that a medicine be placed on their market.

The definition of an unmet medical need, the environmental assessment and the "Bolar exception" are also regrettably weakened in Weiss' draft report. Critical consideration must also be given to an amendment by Wölken that would strengthen the role of the Medicines Shortage Steering Group (MSSG) in the event of supply shortages. Here, the MSSG should also be able to make recommendations on "pricing mechanisms and cost containment measures". However, pricing and reimbursement fall within the scope of a Member State.


The MEPs have set themselves an ambitious roadmap. They would like to reach a parliamentary position on the extensive legislative package before the end of this legislative term, i.e. in April at the latest. Officially, the draft reports will be discussed in the Lead Committee on Environment, Public Health and Food Safety (ENVI) early November. Amendments can be submitted until mid-November.

DSV continues to introduce its positions from the DSV statement. The draft report contains some proposals that, from the DSV's point of view, go in the right direction, but there are still some areas that need to be improved in order to ensure financially sustainable and resilient healthcare systems, the availability of medicines with proven high benefits and high-quality care for the insured.