The EU’s Pharmaceutical Reform Package

The pharmaceutical package was debated in the EU Parliament and on 10 April 2024, the MEPs adopted their position. We have selected some elements of the reform package and described the changes being proposed by the new legislative reforms.

These are still apt to change as they go through the legislative process, and with the change in the EU Presidency, it will be interesting to see their evolution.

Finally, although we have some more topics lined up, we welcome suggestions from readers! Please let us know if there is anything else you would like to see in this blog.

Regulatory Data and Market Protection

Current framework

The current framework provides for:

• 8 years of regulatory data protection
• +2 years of market protection
• +1 year of market protection if the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which are held to bring a significant clinical benefit in comparison to existing therapies

Directive proposed in 2023

The Directive proposed in 2023 provided for:

• 6 years of regulatory data protection
• +2 years if the marketing authorisation holder launches the product in all EU Member States
• +6 months if the product addresses an unmet medical need
• +6 months if comparative clinical trials are carried out for the product
• +12 months if the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which are held to bring a significant clinical benefit in comparison to existing therapies
• +2 years of market protection

Position adopted by MEPs on 10 April 2024

The position adopted by MEPs on 10 April 2024 provides for:

• 7.5 years of regulatory data protection
• +12 months if the particular product addresses an unmet medical need
• +6 months if comparative clinical trials are carried out for the product
• +6 months 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
• +2 years of market protection
• A one-time extension (+12 months) of the 2-year market protection period if a marketing authorisation is obtained for an additional therapeutic indication which provides significant clinical benefits in comparison to existing therapies

Antimicrobial Resistance

Current Framework

The current framework provides for insufficient incentives to combat the growing problem of antimicrobial resistance.

Directive proposed in 2023

The Directive proposed in 2023 provided for a “transferable data exclusivity voucher” to a “priority antimicrobial”, which would give the marketing authorisation holder an additional 12 months of data protection for one authorised medicinal product. It could be applied for when applying for a marketing authorisation and only be used:

• Once
• In relation to a single centrally authorised medicinal product
• If that product is within its first four years of regulatory data protection
• If the marketing authorisation has not been withdrawn

Moreover, it can only be transferred to another marketing authorisation holder once, and the applicant needed to demonstrate capacity to supply the antimicrobial in sufficient quantities for the expected needs of the Union market.

Position adopted by MEPs on 10 April 2024

The position adopted by MEPs on 10 April 2024 provides for a “transferable data exclusivity voucher” to a “priority antimicrobial”, which would give the marketing authorisation holder a maximum 12 months of data protection for one authorised medicinal product. It can be applied for when applying for a marketing authorisation and only be used:

• Once
• In relation to a single centrally authorised medicinal product
• If that product is within its first four years of regulatory data protection
• If the marketing authorisation has not been withdrawn

Moreover, the duration of the transferable data exclusivity voucher will be calculated as follows:

• +12 months of regulatory data protection for developing critical priority antimicrobials
• +9 months of regulatory data protection for developing high priority antimicrobials
• +6 months of regulatory data protection for developing medium priority antimicrobials

The priority of antimicrobials will be designated by delegated acts.

The extra regulatory data protection cannot be applied to medicines that have already reached the maximum 8.5 years of protection.

In order to be granted the voucher, the applicant has to not only demonstrate capacity but also ensure the supply of the antimicrobial in sufficient quantities for the expected needs of the Union market, as defined in a contract with the Health Emergency Preparedness and Response Authority.

Environmental Risk Assessment

Current Framework

The current framework provides for submitting an environmental risk assessment with applications for marketing authorisations, which evaluate possible risks to the environment due to the use and/or disposal of the medicinal product and make proposals for appropriate labelling provisions.

Directive proposed in 2023

The Directive proposed in 2023 provided for a need for the environmental risk assessment to evaluate the risks and the possibility to refuse or revoke a marketing authorisation based on environmental grounds or if the environmental risk assessment is incomplete or insufficiently substantiated.

Position adopted by MEPs on 10 April 2024

The position adopted by MEPs on 10 April 2024 expanded the scope of the environmental risk assessment to include risks to the environment or public health posed by the release of the medicinal product in the environment from its manufacture as well. Their position is also that risk mitigation measures (for avoiding and limiting emissions to air, water and soil) should address the entire lifecycle of medicines.

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*Please note that the content of this blog series is for informational purposes only and does not constitute legal advice. Visitors to this blog should not act upon the information on this website, or decide not to act based upon the information on this website, without first seeking appropriate professional counsel from an advocate licensed to practise in the reader’s jurisdiction.