Today I’m turning this post over to some of my FTI colleagues in Europe (Antoine Mialhe, Katja Murray and Valeria Fagone among others) who helped summarize the Reform of the EU pharmaceutical legislation that the European Union (EU) adopted on April 26, 2023. The summary below is provided by the FTI Consulting team in Brussels and is a very helpful overview. A more detailed analysis is in the PDF link below. There is also a video discussion as well.
THE PHARMACEUTICAL PACKAGE
Widely considered to be the largest overhaul in EU-level pharmaceutical legislation in the last two decades, this package consists of a number of legislative initiatives and non-binding initiatives. Please find an overview of each below as well as key conclusions.
Legislative proposals:
- A Directive on the Union code relating to medicinal products for human use
- A Directive is a legal act of the EU that has to be transposed in national law and leaves leeway as to the exact rules to be adopted by each EU Member State
- This new Directive would amend and replace the existing Directive on the Community code relating to medicinal products for human use as well as incorporate and amend relevant parts of the existing Regulation on medicinal products for paediatric use)
- A Regulation outlining Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency
- A Regulation is a binding EU legislative act which applies in its entirety across the EU
- This new Regulation would amend and replace the existing Regulation on laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the existing Regulation on orphan medicinal products as well as the existing Regulation on medicinal products for paediatric use
Non-binding proposals:
- A Commission Communication on Pharmaceutical Reform and Antimicrobial Resistance (AMR)
- A Communication is a non-binding document that sets out political objectives
- This document is not in the scope of the attached analysis
- A Commission proposal for a Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach
- A proposal for Council Recommendations is an invitation from the European Commission towards Member States to provide their position on a broader issue
- Based on this document, Sweden – the current chair of the Council of the EU – will work with Member States to work on a set of recommendations by June 2023
- This document is not in the scope of the attached analysis
Key conclusions:
The pharmaceutical package touches on 14 issues, ranging from manufacturing to paediatrics to advanced therapy medicinal products and hospital exemptions. Based on our assessment of the key changes, we have identified seven areas that could have substantial impacts on the biopharmaceutical sector: (1) incentives, (2), antimicrobial resistance, (3) shortages and security of supply, (4) reporting on publicly funded financial support, (5) environmental risk assessment, (6) regulatory procedures, (7) manufacturing. The top-line changes in the proposals include:
- Incentives: The baseline regulatory data protection (RDP) is reduced from 8 years to 6 years and the market exclusivity for orphan drugs from 10 years to 9 years. A new modulation system is introduced, meaning that additional years of regulatory data protection and market exclusivity can be granted if a new medicine addresses unmet medical needs (UMN). For orphan medical products (OMP), they will need to address high unmet medical needs (HUMN). Additionally, two years of additional data protection will be granted if a new medicine is launched in all EU Member States (‘providing sufficient supply’)
- Antimicrobial resistance: Transferable data exclusivity vouchers (TEV), granting manufactures of ‘priority antimicrobials’ +1 year of RDP, are introduced
- Shortages: New definitions around ‘shortages’, ‘critical shortage in the Member State’ and ‘critical shortage’, as well as new requirements for marketing authorisation holders (MAH) are proposed
- Reporting on public funding: A responsibility of MAH to declare direct public financial support for R&D of an approved medicinal product is introduced
- Environmental risk assessment: Marketing authorisation (MA) is linked to environmental considerations. As such, if this proposal is adopted, the MA could be refused if the environmental risk assessment (ERA) is not complete or does not address identified environmental risks in a sufficient manner
- Regulatory: Substantial provisions on the European Medicines Agency structure, increased pre-authorisation regulatory support, drug devices combination, the temporary emergency marketing authorisation and the establishment of a regulatory sandbox, as well as e-leaflets & labelling provisions, are introduced
- Manufacturing: Rules on manufacturing, import and export of medicinal products would be subject to a MA granted by a Member State, if the proposal is adopted
THE PATENT PACKAGE
In addition to the pharmaceutical package, the Commission also adopted an EU patent package yesterday, which we expect them to publish today. The patent package consists of multiple proposals spanning several regulatory areas; the two regulatory areas that are most relevant for health and life sciences: Supplementary Protection Certificates (SPCs) and compulsory licensing.
Based on the draft text, the key conclusions are as follows:
- SPCs: The proposals introduce a centralised procedure for granting (unitary) SPCs for medicinal products. The proposals do not amend the substantive elements of the current SPC regime, i.e., the conditions for obtaining SPCs or their legal effects. Only procedural provisions are changed
- Compulsory licensing: The aim of the proposal is to create an EU-level compulsory licensing system to address crises at EU-level by ensuring the supply of crisis-relevant products