The Commission is proposing an ambitious revision of the EU pharmaceutical legislation to achieve the following main objectives:
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
- Reduce drastically the administrative burden by speeding up procedures significantly reducing authorisation times for medicines, so they reach patients faster;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
The revision is the first major review of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.
1. What does the package consist of?
The reform includes two legislative proposals: a new Directive and a new Regulation which constitute the EU regulatory framework for all medicines (including those for rare diseases and for children), simplifying and replacing the previous pharmaceuticals legislation.
Simply put, the Directive contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other regulatory procedures for all medicines authorised at EU and national level.
The Regulation sets specific rules (on top of the ones in the Directive) for medicines authorised at EU level, in particular the most innovative ones. It sets out the rules on coordinated management of critical shortages and security of supply of critical medicines. It also sets out the rules governing the European Medicines Agency (EMA).
The reform also includes a Council Recommendation on antimicrobial resistance (AMR).
Finally, these legislative proposals and Council recommendation are accompanied by a Communication that explains the rationale of the changes.
2. What is new in this reform?
The reform builds on the current high standards of quality, safety, and efficacy for the authorisation of medicines and proposes new tools in the following areas:
- Move away from a “one-size-fits-all” system of incentives for pharmaceutical companies to a modulated system of incentives that rewards companies that fulfil important public health objectives, such as giving access to medicines in all Member States, developing medicines that address unmet medical needs, conducting comparative clinical trials and developing medicines that can treat other diseases as well. For medicines for rare diseases, a similar modulation for market exclusivity is proposed;
- Faster availability of generics and biosimilars and transparency of public funding;
- Addressing shortages of medicines and ensuring security of supply;
- A modern and simplified regulatory framework with faster authorisations of new medicines. For instance, for its assessment, EMA will have 180 instead of 210 days. For the authorisation, the Commission will have 46 instead of 67 days. This will help to reduce the current average of around 400 days between submission and market authorisation. For the assessment of medicines that are of major public health interest, EMA will only take 150 days regulatory sandboxes supporting the development of innovative medicines, electronic submissions and e-leaflets;
- Promotion of innovation and competitiveness;
- Better protection of the environment;
- Tackling antimicrobial resistance (AMR).
3. How will the new legislation promote innovation?
- Many measures have been proposed to support the development of innovative medicines: the authorisation process for new medicines will be sped up, thanks to simplified procedures and a revamped EMA structure.
- Early scientific advice by EMA will improve the quality of applications and tailored scientific support will be provided to SMEs. Learning from the COVID-19 experience, “rolling reviews” (i.e., a phased reviews of data as they become available), and temporary emergency marketing authorisations for health emergencies will be introduced.
- Developers of innovative products will receive advice on their product even years before they actually apply for a marketing authorisation which will facilitate their decisions.
- Regulatory ‘sandboxes’ allow testing new regulatory approaches for novel therapies under real world conditions. The use of real-world evidence and health data is also facilitated. The regulatory framework will be more agile to accommodate scientific advances, digitalisation, artificial intelligence and cutting-edge products.
- Special provisions and incentives for repurposing make it easier for researchers and not-for-profits to materialise their research into authorised medicines.
- Special incentives are given for medicines delivering on high unmet medical needs in the case of rare diseases.
- Companies marketing innovative medicines will have a minimum period of regulatory protection of 8 years, which includes 6 years of data protection and 2 years of market protection. Companies may benefit of additional periods of protection, increasing the total period up to maximum 12 years, while it is maximum 11 years today. These additional periods of protection can be obtained if the companies launch the medicine in all Member States (+2 years), if the medicine addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months). A further year of data protection can be granted if the medicine can treat other disease(s) too. The additional regulatory protection of 2 years if medicines are launched in all Member States is expected to increase access by 15%. This means that 67 million more people in the EU could potentially benefit from a new medicine.
- For medicines for rare diseases, the standard duration of market exclusivity will be 9 years. Companies can benefit from additional periods of market exclusivity if they address a high unmet medical need (1 year), launch the medicine in all Member States (+ 1 year), or develop new therapeutic indications for an already authorised orphan medicine (up to 2 extra years). The regulatory production periods can add up to maximum 13 years while today the maximum is 10 years.
- Moreover, a number of future-proofing measures will ensure that the regulatory system can keep pace with scientific and technological progress. This also comprises promoting innovative methods, including those aimed at reducing animal testing.
All these measures offer an attractive and internationally competitive regulatory protection, which is complementary to the current system of intellectual property rights offering businesses an additional reward for innovation.
4. Will the proposed reform have an impact on the Intellectual Property (IP) protection covering medicinal products?
No. The reform does not affect the EU system of intellectual property protection (IP) (patents, trademarks, copyrights, supplementary protection certificates). That means Europe will continue to offer a globally competitive system of IP incentives.
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