Today, as part of its work to create a future-proof and
crisis-resilient regulatory framework for the pharmaceutical
sector, the Commission has published a public consultation on
the revision of the EU's pharmaceutical legislation. This is
the latest step towards an ambitious reform as announced in the
Pharmaceutical Strategy
for Europe, adopted in November
2020.
Stella Kyriakides, Commissioner for Health and
Food Safety, said: "Today we take an important step for the
reform of EU's pharmaceutical legislation by the end of next
year. A regulatory framework for pharmaceuticals, which is
modernised and fit for purpose, is a key element of a strong
European Health Union and crucial to addressing the many
challenges this sector is facing. I call on all
interested citizens and stakeholders to help us shape EU rules
for the future, responding to patients' needs and keeping our
industry innovative and globally competitive."
The consultation, which will run for twelve weeks, until 21
December, will gather the views from both the general public
and stakeholders to support the evaluation of and the impact
assessment for the revision of the EU's pharmaceutical
legislation. Today's development follows on from the public
consultation
conducted for the preparation of the Strategy itself.
Since the adoption of the Strategy, the Commission has been
working on a number of actions in close cooperation with Member
States' authorities, the European Medicines Agency and with
stakeholders' organisations. A major flagship action is the
revision of the general pharmaceutical
legislation, foreseen for end 2022, which is also being
supported by an ongoing study. Other flagship actions of the
Strategy focus on Health Technology Assessment, EU Health Data
Space, legislation on rare diseases and medicines for children
and strengthening the continuity and security of supply of
medicines in the EU.
This public consultation launched today notably addresses:
- The performance of the EU's pharmaceutical legislation;
- Unmet medical needs;
- Incentives for innovation;
- Antimicrobial resistance;
- Future-proofing the regulatory framework for novel
products;
- Improved access to medicines;
- Competitiveness of the European markets to ensure
affordable medicines;
- Repurposing of medicines;
- Security of supply of medicines;
- Quality and manufacturing of medicines;
- Environmental challenges.
Background
The last comprehensive review of the general pharmaceutical
legislation was tabled almost 20 years ago. Since then.
societal and scientific changes, as well as new areas of
concern such as antimicrobial resistance, environmental
challenges and shortages of medicines, have emerged. In that
context, the Pharmaceutical Strategy adopted in November 2020
includes an ambitious agenda of legislative and
non-legislative actions to be launched over the coming
years and has four main objectives:
- Ensuring access to affordable
medicines for patients, and addressing unmet medical
needs (e.g. in the areas of antimicrobial resistance, cancer,
rare diseases);
- Supporting competitiveness, innovation and
sustainability of the EU's pharmaceutical industry and
the development of high quality, safe, effective and greener
medicines;
- Enhancing crisis preparedness and response
mechanisms, and addressing security of supply;
- Ensuring a strong EU voice in the world, by
promoting a high level of quality, efficacy and safety
standards.
More Information
Consultation
A Pharmaceutical
Strategy for Europe
European Health
Union
