EUROPABIO The strategy must have a strong focus on innovation as a growth engine and ensure the
st give the right signal that we are encouraging
investments through IP stability (longevity and predictability of the framework). CAB: noted that
innovation should serve the needs of patients and stressed that it is important to have a strong IP rights
system and smart incentives that encourages R&D and delivers products at affordable price.
Supply chain and global resilience
EUROPABIO mentioned that 80% of available medicines in EU originate in Europe. We must make sure
the single market is working and keeping the flow of medicines.
CAB mentioned that we should look at Covid lessons. We know that ecosystem has to deliver outcomes
even under conditions of stress. In the SOTEU address the President mentioned the strengthening of the
EMA role and ECDC. EMA has shown its flexibility in the crisis, we must make some of these learnings
permanent. We also need a more European system on HTA.
GMOs
EUROPABIO asked if the EC sees any changes as regards GMOs given the learnings of Covid.
CAB mentioned the specific characteristics of medicines for human use and indicated that the
chal enges of the application of GMOs rules to human medicines wil be assessed as part of the pharma
strategy.
Incentives
EUROPABIO asked if it would be possible to clarify what measures are considered, legislation with non-
legislative instruments?
CAB replied that different approaches are being examined. A unitary SPC procedure could be part of the
solution.
Manufacturing in EU
EUROPABIO noted the complexity of the manufacturing of biologicals such as ATMPs and stressed the
benefits for society of attracting manufacturing of high-value products to the EU (highly qualified jobs,
economic development). It noted that EU should not repeat what happen with generics (by focusing
only on prices and neglecting other benefits, manufacturing has moved elsewhere). According to
EUROPABIO the fol owing can help to bring back manufacturing: a quality of workforce, link with
universities, a favourable fiscal regime and regulatory environment (predictability/certainty), access to
customers, capital intensive investments.
CAB: Noted the suggestions.
Access and affordability
EUROPABIO mentioned that the role of EMA is crucial in terms of acceleration the assessment times
and cooperation with agencies (the cooperation we saw in Covid should be continued). Accelerated
access also relates to the HTA debate and the efficiency of the EU regulatory system (average time for
assessment of MAAs in EMA is 423 days in EU vs 300+ in US). Shorter assessment timelines wil lead to
earlier access. It reiterated that the IP front needs to be stable because if you reduce IP rights or
introduce obligations this wil inevitably inhibit access.
CAB noted the comment but maintained that a balance needs to be found between access and
incentives. It also asked EUROPABIO to come back with proposals in areas other than Pharma which
would be beneficial for the competitiveness of the sector.
ENDS