On 26 April 2023, the EU Commission made a proposal to overhaul the current EU pharmaceutical legislative regime, and introduce legislation that will create new rules for access to the market for medicinal products. This package of legislative reforms – one regulation and one directive - is introduced against the backdrop of the 2020 Pharmaceutical Strategy for Europe and its broad objective of improving access to medicine across the single market following on from the COVID-19 pandemic.
One of the most significant aspects of the reform is the proposal to reduce the standard period of regulatory protection from 10 years to 8 years (6 years of data protection plus 2 years of market protection) – extendable up to 12 years provided that certain conditions are met. These conditions are intended to incentivise the availability of medicines and research into treatments for rare diseases.
Under the current draft regulations, this 8 year period can be extended:
- By 2 years if the medicine is made available across all member states;
- By 6 months if the medicine addresses an 'unmet need';
- By 6 months if the medicine contains a new active substance and undergoes a comparative clinical trial; and
- By 1 year if a new, beneficial 'therapeutic indication' has been approved for the medicine (this extension can only be granted once).
A designed 'orphan medicinal product' (used to diagnose, treat, or prevent rare diseases) will have a period of regulatory protection of 9 years, extendable up to 13 years in circumstances where the medicine is available across the EU and addresses a 'high unmet need'.
The package of reforms also proposes a number of other key changes to the regulatory regime, including:
- Novel antimicrobials: The introduction of measures to encourage the innovation of novel antimicrobials to avoid the development of antibiotic resistant bacteria – developers of 'priority antimicrobials' may be entitled to an additional 1 year of regulatory protection;
- Disclosure requirements: Pharmaceutical companies will be required to publish information about the financial support they have received from public bodies for the research and development of medicines;
- 'Regulatory Sandbox': The 'regulatory sandbox' will allow for the testing of new regulatory approaches for novel therapies under 'real world conditions'; and
- Environmental risk assessment ("ERA"): All pharmaceutical companies placing their medicines on the EU market will be required to complete an ERA assessing the impacts of their medicines on the environment and public health.
While it remains to be seen the extent to which these proposals in their current format will make their way through what is likely to be a lengthy legislative process, given the substance and significance of the proposed reforms, this proposal indicates that important changes are coming down the tracks for the pharmaceutical industry in the EU.
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