The EU pharmaceutical package – overview and outlook

What is it all about?

The EU pharma package includes a draft regulation and a draft directive, which will significantly reshape the European legal framework for pharmaceutical law. These drafts, which were already adopted by the European Parliament in April 2024, were preceded by a recommendation on combating antimicrobial resistance from the European Commission and a statement on the reform of pharmaceutical law. This is the largest reform of EU pharmaceutical legislation in around two decades.

The package aims to accelerate access to innovative medicines and improve it through economic incentives as well as the reduction of bureaucratic hurdles. Additionally, the new regulations aim to advance the development of medicines for children and rare diseases, make medicines more environmentally friendly, and intensify the fight against antimicrobial resistance. Entirely new aspects, not previously addressed in EU pharmaceutical legislation, such as supply security and the importance of approval documents for Health Technology Assessments (HTAs), will also be addressed. In addition, equal access to medicinal products throughout the EU is to be strengthened through a number of new approaches.

A single blog post is nowhere near enough to cover all the details of the comprehensive drafts and accompanying documents. However, a few key areas that are currently at the center of discussions are highlighted below. The package is likely still not fully “finalized.”

Changes to data protection

Currently, the basic rule provides for 8 years of data protection for all pharmaceuticals. This data exclusivity period is followed by two years of market protection, during which generics manufacturers can already view the documents and apply for approval, but are not yet allowed to market their products. An additional year of market exclusivity is available if a new indication is developed

The draft directive provides for significant changes in this regard: The basic protection period is now only to be 6 years, with 7.5 years having been proposed by the European Parliament during the revision process. An additional year of market exclusivity is planned if a new indication is approved within the first eight years and an additional clinical benefit compared to existing therapies can be demonstrated in the approval process.

A new approach in the draft directive is to grant an additional two years of data protection if the medicinal product is placed on the market in all member states within two years (or three years in special cases) (see Art. 81 para. 2 (a) and Art. 82 draft directive).A particularly critical issue here is that it is unclear when a medicinal product is considered to have been placed on the market. In many cases, completing the 27 reimbursement procedures within this timeframe would not be feasible. Another new concept is the so-called “unmet medical need” (Art. 83 draft directive). According to the draft directive, an additional six months of data protection is to be granted if the product addresses such a need. However, the definition in the draft is extremely narrow, meaning that this is still under discussion.

The European Parliament’s proposal also provides for a modular system, but with a different structure: an additional period of 12 months of data protection (instead of 6 months) is granted if a medical supply gap is closed. Further 6 months are granted if the manufacturer carries out comparative clinical trials and another 6 months if a significant proportion of the research and development (including preclinical and clinical trials) is carried out within the EU – partly in collaboration with public institutions. The Parliament’s proposal also removes the controversial market launch requirement and instead introduces an obligation to submit reimbursement applications (“P&R”) at the national level. The period of data protection is followed by 2 years of market exclusivity. This can be extended by 12 months if an important new indication is added, instead of the additional 12 months of data protection proposed by the Commission. However, the total period of data protection is capped at 8.5 years.

The so-called “repurposing” is also new: for pharmaceuticals that have been approved for at least 25 years and for which a new indication is identified, a four-year protection period can be applied for (see Art. 84 draft directive).

Special innovations, which are also graduated in more detail, are set to come into effect for medicines for rare diseases and pediatric medicines. These also provide for a graduated system of data protection and market exclusivity. Orphan medicinal products are automatically classified “as addressing an unmet medical need” (Art. 83 para. 2 draft directive). Section 7 of the draft directive and Chapter VII of the draft regulation outline the changes to the rules for pediatric medicines.

Antimicrobials

After identifying a market failure for antimicrobials (as there is no incentive to develop them at great expense when they are only used as a “backup” in case of resistance to the primary product and therefore do not generate sufficient revenue), the European Commission has introduced an entirely new incentive system to pharmaceutical law in Art. 40 et seq. of the draft regulation:

This system grants developers of innovative antimicrobials transferable data exclusivity vouchers. The holder of such a voucher can use it for their own antimicrobial products, apply it to other pharmaceuticals or transfer it once to another manufacturer. According to Art. 40 para. 2 and Art. 41 of draft regulation 2023/0131 (COD), this voucher grants the holder an additional year of data protection against competitors.

Changes to the approval procedure

To avoid duplication of work in approval applications, reduce administrative and financial burdens, and accelerate the process, the approval procedure is set to be revised. The regulations for the purely national approval procedure, the decentralized approval procedure and the mutual recognition procedure are regulated in the draft directive, while the draft regulation contains the centralized approval procedure.

All procedures included in the draft directive foresee a reduction in the (maximum) duration of the procedure, which should have a significant overall impact, mainly achieved by shortening the deadlines for the individual procedural steps. Such an acceleration is also provided for in the centralized authorization procedure, so that the maximum duration should only be 180 days instead of the previous 210 days (Art. 6 para. 6 draft regulation).

Advertising of medicinal products & free samples

The draft directive also contains significant changes in the area of pharmaceutical advertising. These include, in particular, the expansion of the definition of advertising of medicinal products (Art. 175 of the draft directive), which now also covers product range advertising. This codifies the landmark ECJ ruling (ECJ 7/15/2021, C-190/20, Doc Morris).

The draft directive also includes new provisions on comparative advertising. These include, in particular, a ban on negatively highlighting another medicinal product and a ban on presenting the advertised medicinal product as safer or more effective if this is not demonstrated and supported by the summary of product characteristics (Art. 176 draft directive).

The group of persons who are allowed to distribute free samples has been extended. Now, in the case of non-prescription medicinal products, not only persons authorized to prescribe (usually doctors) but also persons authorized to dispense (various healthcare professions, nursing staff) may do so, see Art. 185 para. 2 of the draft directive. This amendment was also made in view of a groundbreaking ECJ decision (ECJ 7/11/2020 C-786/19, ratiopharm GmbH/Novartis Consumer Health GmbH).

Outlook

As outlined, several aspects remain unclear, and the full scope of the changes will only become evident once the finalized agreements are reached. The current Polish Council Presidency has already announced plans to continue advancing the revision of pharmaceutical legislation in 2025.Companies are already well advised to deal in particular with the completely new aspects, such as driving forward the development of marketing competence in all member states, evaluating repurposing options at an early stage and assessing the potential purchase of vouchers.

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Disclaimer

This article is for general information only and does not replace legal advice. Haslinger / Nagele Rechtsanwälte GmbH assumes no liability for the content and correctness of this article.

 

27. January 2025

 

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