Your opinion matters: the public consultation on the review of EU pharmaceutical legislation is now open
On September 28, 2021, the European Commission officially opened the public consultation on the review of the EU’s general pharmaceutical legislation. The consultation period will last 12 weeks, until December 21, 2021. The general public, citizens, businesses, civil society, public authorities, healthcare providers or any other interested and / or likely stakeholder to be concerned, are invited to provide their comments. on the “Have your say” portal.
The public consultation offers a unique opportunity for the parties concerned to share their views on the expected changes according to their own specific needs and expectations. The European Commission will consider the comments collected to assess the impact assessment and help shape the legislative proposal it presents by the end of next year.
As discussed in our previous publication, this revision concerns the general pharmaceutical legislation of the EU – Directive 2001/83 / EC1 and regulation 726/20042. The changes are driven by the need to have better access to affordable medicines, to foster innovation, to improve security of supply, to adapt to new scientific and technological developments and to reduce red tape. The European Commission welcomes the views of the public on a variety of areas.
The public consultation covers the following points:
- The performance of EU pharmaceutical legislation;
- Unmet medical needs;
- Incentives for innovation;
- Antimicrobial resistance;
- to perpetuate the regulatory framework for new products;
- Improved access to medicines;
- Competitiveness of European markets to guarantee affordable medicines;
- Reallocation of drugs;
- Security of drug supply;
- Quality and manufacture of drugs;
- Environmental challenges.
These specific points are available in all official EU languages and responses can also be submitted in any official EU language.
An ongoing study also supports the public consultation. Once the 12-week consultation period is over, the European Commission will analyze the feedback and hopes to adopt a final legislative proposal by the fourth quarter of 2022. The type of legislative act currently under consideration is a regulation, which would have a significant impact on direct applicability, readiness and compliance for stakeholders.