increase supply (up to 800% increase over the same period in 2019). This was partly due to a strong
manufacturing footprint in EU.
Pharmaceutical Strategy
MfE: Stressed that even though EU manufacturing of medicines stil exists, increases in manufacturing
cost (average cost in off patent sector in Germany is 17 cents today compared to 6 cents 10 years ago)
causes a move of manufacturing from west to east. EU MS must introduce MEAT (most economical y
advantageous) criteria for pharmaceuticals procurement in off patent medicines with a combination of
other factors like quality and guarantee of supply. Multi-winner procurement should be the rule.
Regulatory dialogue through regular cal s should be kept. y. The public procurement directive already
recommends the use of MEAT criteria, this should be fol owed by al MS.
MfE mentioned that generics, biosimilars and added value medicines are part of solution as their impact
on budget is minimal. However, in some MS (especial y in eastern Europe) there are stil severe access
restrictions - especial y for biosimilars. Clawbacks and other funding techniques make off patent
manufacturing non sustainable and redirect funds to finance the high cost of innovative medicines. For
example in the area of antibiotics some of which are extremely cheap production is not sustainable
which may lead to withdrawals which in turn decrease therapeutic options. Regulatory cost and
maintenance costs of such products are driving these withdrawals. The strategy should include actions
to improve regulatory processes to help the maintenance of wel -established products. The variations
procedure should be simplified by reducing the administrative burden for reporting. The nature of 50%
of variations today is purely administrative. We can use digital tools to turn this paper process into a
digital one. The goal should be to reduce by at least 50% this administrative waste. Also the Commission
should create a tailored pathway to develop follow-on products which wil bring affordable options to
the market. Other bottlenecks include patent ever greening, patent linkage (a generic company cannot
register a generic if a patent is stil valid), the harmonised implementation of the Bolar exemption,
uptake of biosimilars (in eastern Europe mostly). The last can be tackled by providing incentives for
prescription.
The Commission should look into the root causes of shortages (Covid related shortages were mostly
about demand spikes and only 3% were quality related). MfE supports the provision of obligation to
supply (already included in legislation). MfE stressed that the current API manufacturing base is strong
(400 production sites in EU). The EU should promote investment in critical manufacturing infrastructure.
The creation of a European medicines supply committee could help. Also, as part of the Green deal, it
should promote investments in green manufacturing in the EU. Overal financial support should be
combined with market incentives.
The EU should work with international partners to avoid export restrictions and enforce GMP rules.
Final y, MfE reiterated its cal for a multi stakeholder forum which would facilitate discussion on access.
DG SANTE: Recognised the importance of the generics industry in the strategy. Off patent innovation
and access are priorities in the roadmap which is only an outline there point wil be reinforced in the
strategy communication. Patents, the Bolar exemption, procurement are al issues the Commission
services are working on (together with DG Grow). Variations is an area we are committed to look at as
part of evaluation and possible review of legislation.
Commissioner Kyriakides: The role of generics wil strengthen the strategy which wil be as inclusive as
Access/affordability/digitalisation wil be addressed in the strategy. An open channel of communication
and ongoing engagement is crucial.