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
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.