Access to medicines and strengthening open strategic autonomy
–
the role of the
Pharma package
The ongoing negotiations on a revision of
Commission’s
pharmaceuticals package will play a significant
role in defining and determining the regulatory framework for
patients’ access to novel treatments and
innovative medicines and the European pharmaceutical industry's ability to compete globally.
The pharmaceutical package is timely and necessary, and the Commission's proposal includes many
promising elements. However, we are concerned that some of the proposed incentives for industry and
requirements related to security of supply will not provide an enabling framework for innovation nor
make the EU an attractive market for the newest and most effective treatments.
Furthermore, the pharma package cannot be insulated from horizontal political priorities in the EU and
must contribute to strengthening
the EU’s
global competitiveness, decreasing strategic dependencies and
mitigating critical supply shortages. The pharmaceuticals package should play an important role in
strengthening the EU's open strategic autonomy by reinforcing the European pharmaceutical
industry’s
capacity to develop and provide new medicines and life-changing technologies for all Europeans.
We are especially concerned about reducing incentives for developing innovative medicines in Europe
and creating unnecessary bureaucracy for pharmaceutical companies, especially when it comes to regu-
lating incentives and security of supply. An example of this is the proposal to reduce the data protection
period for innovative medicines and replace it with a complicated spectrum of incentives that make the
investment case and market potential for innovative medicines more unpredictable and uncertain. An-
other example is the extensive reporting obligations on pharmaceuticals that will be costly for both sup-
pliers and Member States without providing a proportional improvement in security of supply. In fact,
these additional burdens may in themselves be barriers for producers to supply innovative medicines and
generics to the European market and result in fewer treatments being available to patients in the member
states.
Transparency and predictability are essential for the pharmaceutical industry's ability to develop and mar-
ket new, innovative medicines in Europe. Medicines that could help patients across the EU improve their
quality of life. The proposed set of bureaucratic hoops that industry will have to jump through will in-
crease uncertainty and place a substantial administrative burden on Member States. The proposed ap-
proach is
counterproductive to the EU’s
strategic objectives of reducing bureaucracy in order to
strengthen competitiveness and open strategic autonomy.
There is a need for an alternative approach that address the issues of access to medicines whilst provid-
ing industry with strategic incentives that contribute to improving health care and achieving our politi-
cal goals. When it comes to data protection, we see the need to preserve the current regulatory data
protection period and build a simpler and more predictable incentive structure. When it comes to secu-
rity of supply we see the need for less bureaucracy and more concrete initiatives such as a voluntary as-
sistance mechanism that can facilitate the efficient exchange of critical medicines between member
states’ stocks when shortages occur.
This assistance mechanism should include a methodology for fair
compensation for assistance provided by Member States.
We trust the Presidency will consider our concerns and our ambitions on how incentives in the pharma-
ceuticals package can contribute to achieving our twin political goals
of strengthening Europe’s
economic
security as well as improving all Europeans’ access to
innovative medicines.