On Wednesday 26 April, the European Commission proposed an ambitious revision of the European Union’s pharmaceutical legislation in order to create a single market for medicines, reduce authorisation time for medicines and step up the fight against antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment.
This revision is the first major update of the pharmaceutical legislation since 2004. It will adapt legislation to the needs of the 21st century.
The reform includes two legislative proposals: a new directive and a new regulation, which will form the EU regulatory framework for all medicines (including those for rare diseases and paediatric use) and will simplify and replace previous legislation.
The reform includes an EU Council recommendation on antimicrobial resistance (AMR).
Commission Vice-President Margarítis Schinás replied that he hoped the package would be adopted “as soon as possible”, without saying whether this would be possible before the end of the mandate.
Innovations. A number of measures have been proposed to support the development of innovative medicines: the authorisation process for new medicines will be accelerated by simplifying procedures and restructuring the EMA. Early scientific advice from the EMA will improve the quality of applications and tailored scientific support will be provided to SMEs. Based on the lessons learned from Covid-19, ‘rolling assessments’ (a progressive review of data as they become available) and emergency temporary marketing authorisations for health emergencies will be introduced. In addition, regulatory sandboxes will be used to test new regulatory approaches to new therapies under real-life conditions.
Special incentives are provided for medicines addressing significant unmet medical needs for rare diseases.
Companies marketing innovative medicines will enjoy a minimum regulatory protection period of 8 years, including 6 years of data protection and 2 years of market protection. Companies will be able to benefit from additional periods of protection, bringing the total duration of protection to a maximum of 12 years, compared to the current maximum of 11. Companies can benefit from these additional periods of protection if they 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 carried out (+6 months). An additional year of data protection may be granted if the medicine can treat other diseases as well. The additional 2 years of regulatory protection if the medicine is 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 drug.
For medicines for rare diseases, the standard duration of market exclusivity will be 9 years. Companies will be able to benefit from additional periods of market exclusivity if they address a significant unmet medical need (+1 year), launch the drug in all Member States (+1 year) or develop new therapeutic indications for an already authorised orphan medicine (+2 years maximum). In total, the regulatory protection period will be up to 13 years, compared to a maximum of 10 years today.
Addressing shortages. The reform introduces new requirements for the monitoring of medicine shortages by national authorities and the EMA, as well as an enhanced coordination role for the EMA. The obligations for companies will be strengthened, including earlier notification of shortages and withdrawals of medicines and the establishment and maintenance of shortage prevention plans.
An EU-wide list of critical medicines will be drawn up; vulnerabilities in the supply chain of these medicines will be assessed and specific recommendations will be made on actions to be taken by companies and other stakeholders in the supply chain. In addition, the Commission may adopt legally binding measures to enhance the security of supply of certain critical medicines.
In addition, better enforcement of current environmental standards will limit the potential adverse effects of medicines on the environment and public health.
AMR. The reform provides incentives, in the form of transferable vouchers, to companies that invest in novel antimicrobials capable of treating resistant pathogens, thus addressing the current market failure. The voucher will give the developer an additional year of data protection from competition for the medicine to which the voucher applies. The vouchers will be granted and used under strict conditions. They will be granted in limited numbers for a limited period of time (no more than 10 vouchers in 15 years), which will limit the burden on health systems. “There will be full transparency”, assured Health Commissioner Stella Kyriakides.
Véronique Trillet-Lenoir (Renew Europe, French) welcomed the package, but said that antimicrobial resistance should be tackled through innovative solutions, reduced prescribing and a stronger role for HERA (the new European health authority) in the search for new antibiotics, rather than through a voucher system. This proposal would “only increase the risk of the manufacturer using this ‘voucher’ for any medicine in its catalogue, thus reducing access to it”, she said.
For Nathalie Colin-Oesterlé (EPP, French), the proposal “puts pressure on industry”. We must not lose sight of the importance of reindustrialising Europe by encouraging manufacturers to “repatriate the entire production chain to our continent, from R&D to manufacturing”.
“This proposal remains at the service of industry, in the name of patient interest. This bothers me!”, said Michèle Rivasi (Greens/EFA, French). She believes that this text, under the guise of addressing urgent issues, such as the shortage of medicines, pharmaceutical pollution or antibiotic resistance, “promotes a scheme that in reality leaves power to the goodwill of industry”. Link to all the texts in the package: https://aeur.eu/f/6k4 (Original version in French by Lionel Changeur)