Danish non-paper on the revision of the EU pharmaceutical legislation
Europe is faced with a unique chance to position itself in the global race of developing and deliv-
ering healthcare solutions in a resilient manner to patients. This requires a resolute and visionary
effort that leverages innovation, industrial and public capabilities and accessibility of medicines
to patients through a future-proof pharmaceutical regulatory framework.
The upcoming revision of the pharmaceutical legislation is an opportunity to address three key
challenges for Europe: 1. How to ensure timely access to affordable medicine for all Europeans,
2. How to support Europe’s ability to innovate and play a leading role in developing
new medi-
cines, and 3. Enhance security of supply of pharmaceuticals and thereby strengthening European
open strategic autonomy in this vital area, while taking environmental impacts into consideration.
We see several interesting elements among the considerations of the Commission such as repur-
posing medicine, streamlining the approval processes and accommodating new concepts of adap-
tive clinical trials and real-world evidence. These measures will contribute to the accessibility and
to the future-proofing of the legislative framework. Development of medicines that address un-
met medical needs including novel antimicrobials is also needed. Further, we welcome the Com-
mission’s focus on security of supply which is becoming increasingly important. The same goes
for the Commissions focus on the environmental impact of producing pharmaceuticals. This is a
very welcome step which could make important contributions towards the tackling of the climate
crisis.
While the upcoming proposal is timely and necessary, Denmark has deep concerns that some of
the measures under consideration to ensure better access to affordable medicines in all Member
States will not solve the current problems and could in fact lead to adverse consequences for
Europe and
European life science industry’s innovation capacity to develop
and provide new med-
icines to Europeans.
Access to affordable medicine for all Europeans
Multiple factors influence patients’ access to medicines and ensuring better access is a shared
responsibility between industry, national authorities, and the European level. It is important that
all Member States, including smaller countries with limited markets, have access to affordable
medicines. At European level we should encourage sharing of best practices among Member
States, notably on sharing data, ensuring transparency of national processes and efficient admin-
istrative procedures.
The idea under consideration to reduce the period of regulatory data protection for companies
is a cause for deep concern as it may have adverse impacts. A reduction of the data protection
period
increases the uncertainty for companies’ investments and
may lead to fewer new medi-
cines for patients and make EU less attractive for placing research, development and production.
Further, we do not believe that making a conditional period of the regulatory data protection to
companies launching new medicines in all Member States will improve access to medicines for
the patient. For that reason, new incentives should be added to already existing incentives. Den-
mark therefore proposes an alternative and more balanced tool based on the principle of shared
responsibility with the following main elements:
•
An obligation for companies to report on plans for marketing of products in the Member
States, if the companies have not taken steps to market in all Member States within a
reasonable time. Alternatively, an obligation to file for pricing and reimbursement in all
Member States.
This could be supported by efforts to ensure better transparency on national processes
for reimbursement and launch status.
•