On Tuesday, the Environment, Public Health and Food Safety Committee adopted its position on the new directive (66 votes in favour, two against and nine abstentions) and regulation (67 votes in favour, six against and seven abstentions) covering medicinal products for human use.
Regulatory data and market protection: incentives for innovation
To reward innovation, MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation.
Pharmaceutical companies would be eligible for additional periods of data protection if the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and half years.
A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains a marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.
Orphan drugs (medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”.
Step up the fight against antimicrobial resistance (AMR)
MEPs underline the need to boost the research and development of novel antimicrobials, notably through market entry rewards and milestone reward payment schemes (e.g. early-stage financial support upon achieving certain R&D objectives prior to market approval). These would be complemented by a subscription model-based voluntary joint procurement scheme, to encourage investment in antimicrobials.
They agree with the introduction of a “transferable data exclusivity voucher” for priority antimicrobials, providing for a maximum 12 additional months of data protection for an authorised product. The voucher could not be used for a product which has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorisation holder.
Among the new measures to promote the prudent use of antimicrobials, MEPs want stricter requirements, such as restricting the prescriptions and dispensation to the amount required for the treatment and limiting the duration for which they are prescribed.
Strengthened requirements for environmental risk assessment
These new rules would require companies to submit an environmental risk assessment (ERA) when requesting a marketing authorisation. To ensure adequate evaluation of ERAs, MEPs want the creation, within the European Medicines Agency, of a new ad-hoc environmental risk assessment working party. MEPs insist that the risk mitigation measures (taken to avoid and limit emissions to air, water and soil) should address the entire life cycle of medicines.
Increased independence for EU health emergency body
To effectively address public health challenges and boost European research, MEPs want the European Health Emergency Preparedness and Response Authority (HERA, currently a Commission department) to become a separate structure under the European Centre for Disease Prevention and Control (ECDC). HERA should primarily focus on the fight against the most urgent health threats, including antimicrobial resistance and medicine shortages.
More details on MEPs’ specific proposals are available in this background document.
Quotes
Rapporteur for the directive Pernille Weiss (EPP, DK) said: “The EU pharmaceutical legislation revision is vital for patients, industry and society. Today’s vote is a step towards delivering the tools to tackle present and future healthcare challenges, particularly for our market attractiveness and medicine access across EU countries. We hope Council takes note of our ambition and commitment to create a robust legislative framework, setting the scene for prompt negotiations.”
Rapporteur for the regulation Tiemo Wölken (S&D, DE) said: “This revision paves the way to addressing critical challenges such as medicines shortages and antimicrobial resistance. We are strengthening our healthcare infrastructure and reinforcing our collective resilience ahead of future health crises – a significant milestone in our pursuit of fairer, more accessible healthcare for all Europeans. Measures improving access to medicines, whilst incentivising areas of unmet medical needs, are crucial parts of this reform.”
Next steps
MEPs are scheduled to debate and vote on the Parliament’s position during the 10-11 April 2024 plenary session. The file will be followed up by the new Parliament after the European elections on 6-9 June.
Background
On 26 April 2023, the Commission put forward a “pharmaceutical package” to revise the EU’s pharmaceutical legislation. It includes proposals for a new directive and a new regulation, which aim to make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards.
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