On 26 April 2023, the European Commission published two legislative proposals - a new Regulation 2023/0131 and a new Directive 2023/0132 - to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children).
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 the EU and national level. The Regulation sets specific rules (on top of the ones in the Directive) for medicines authorised at the EU level, in particular the most innovative ones.
The proposals aim to reduce costs, expedite the introduction of new medicines and prevent medicine shortages.
The key points under the new Regulation and the new Directive are as follows:
- Reduced Market Exclusivity Period
- The length of the minimum market exclusivity period that new medicines receive before generics or biosimilars can enter the market will be reduced from 10 years (eight years of data exclusivity and two years of market exclusivity) to eight years (six years of data exclusivity and two years of market exclusivity). However, new medicines may benefit from additional periods of protection, increasing the total period up to a maximum of 12 years (while it is currently a maximum of 11 years), with additional increments being available in the following circumstances: (a) the new medicine is launched in all EU Member States (an additional two years); (b) the new medicine addresses an unmet medical need (an additional six months); (c) comparative clinical trials are conducted (an additional six months); or (d) a new therapeutic indication is developed (an additional one year).
- Medicines for rare diseases (i.e. orphan medicines) have a separate set of new requirements in relation to the market exclusivity period. The standard market exclusivity period will be reduced from 10 years to 9 years. However, orphan medicines may benefit from additional periods of protection, increasing the total period up to a maximum of 13 years, with additional increments being available in the following circumstances: (a) the medicine is launched in all EU Member States (an additional one year); (b) the medicine addresses a high unmet medical need (an additional one year); or (c) a new therapeutic indication for an already authorised orphan medicine is developed (up to an additional two years).
- Faster Approval of New Medicines
- The timeframe of the medicines approval procedure will be reduced from the current average of 400 days through: (a) shortening the assessment periods at the European Medicines Agency (EMA) and the European Commission; and (b) simplifying the EMA’s structure to two main scientific assessment committees for human medicines: the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee (as a result, the current orphan, paediatric, and advanced therapy medicinal product committees will be discontinued).
- The “rolling review” system will be adopted. This system was developed to speed up the approval of COVID-19 vaccines, and involves regulators examining clinical trial data as it becomes available (as opposed to waiting to assess a single submission once all clinical trials have concluded).
- Managing Shortages of Critical Medicines
- An EU-wide list of critical medicines will be established. Recommendations on measures to be taken will be made to companies to strengthen the supply chains of those medicines, including requirements to establish contingency stocks.
- Other Elements
- Companies that develop new antimicrobials that tackle antimicrobial resistance can be awarded a “transferable data-exclusivity voucher”, which would grant an additional year of data exclusivity for any medicine, and can be sold to other companies. The vouchers will be granted and used under strict conditions. They will be provided in limited numbers over a limited period (no more than 10 vouchers in 15 years).
- Pharmaceutical companies will be required to publish information on all direct financial support for the research and development of medicines received from public authorities or publicly funded bodies.
- The European Commission will strengthen the use of the environmental risk assessment (ERA) of medicines to limit the potential adverse impacts of medicines on the environment and public health. The ERA is currently mandatory for all pharmaceutical companies placing their medicines on the EU market. However, under the proposals, medicines approvals may be refused when companies do not provide adequate evidence that environmental risks were evaluated, and risk mitigation measures were taken.
What Happens Next?
The European Commission will now provide the legislative proposals to the European Parliament and the European Council for their consideration. Given the size and political sensitivity of the legislative proposals, it is difficult at this stage to state when they will be given final approval.
Goodwin will be publishing more detailed analysis on elements of the new regulatory framework in the coming days.