The Bolar exemption in the new EU pharma package proposal

Work on the Pharma Package is currently underway in the European Union, following an initiative launched by the European Commission in April 2023. In recent months, significant progress has been made. During the Polish Presidency of the Council of the European Union, the Council adopted its position, which was finalized in early June this year. At present, the Council is negotiating with the European Parliament and the European Commission. If adopted, the package will represent the first comprehensive reform of the EU’s legal framework for the pharmaceutical sector in over 20 years.

The project offers a number of noteworthy solutions concerning, i.a., the support for the treatment of rare diseases, responding to medicine shortages, making approval processes for medicines more efficient, and pharmaceutical products more sustainable. Notably, it includes several innovative proposals concerning the Bolar exemption, which we take a closer look at. It remains to be seen whether, if the project is adopted, it will mark the definitive end of patent linkage in the EU; the impact of the project on the patent linkage is understood not only as the connection between granting a marketing authorisation and the patent status of the original medicine, but more broadly as the influence of that patent status on pricing, reimbursement, or public procurement decisions.

The Bolar exemption: current legal framework

The Bolar exemption plays a crucial role in ensuring timely access to off-patent medicines, which aligns with one of the main objectives of the Pharma Package. It allows generic drug manufacturers to begin developing substitutes while the original drug remains under patent protection, enabling market entry immediately after patent expiry. Without such a provision, patent holders could effectively maintain a monopoly even after their exclusive rights have formally ended.

Currently, the Bolar exemption is established in Article 10(6) of Directive 2004/27/EC of the European Parliament and of the Council, amending Directive 2001/83/EC. According to this article, when studies and trials are necessary for demonstrating that a medicinal product is a generic version of a reference product and carrying out the associated practical requirements, conducing of such studies and trials  shall not be considered an infringement of patent rights or supplementary protection certificates.

Although the EU provisions in question clearly prohibit linking the approval of a generic medicine to the patent status of the original product, the matter becomes less straightforward when it comes to aspects such as setting the medicine’s price or determining reimbursement. In these areas, the practices of EU Member States remain inconsistent.

Strengthening the Bolar Exemption under the Pharma Package

The Pharma Package proposes a significant strengthening of the Bolar exemption. A directive within the package introduces Article 85, entitled “Exemption to the Protection of Intellectual Property Rights.” Under the Council’s position, this provision clarifies that patent rights or supplementary protection certificates shall not be infringed when studies, trials, and other necessary activities are conducted for the following purposes:

• Obtaining marketing authorization for medicinal products, including generic, biosimilar, hybrid, or bio-hybrid medicines, and for subsequent variations;
• Conducting health technology assessments as defined in Regulation 2021/2282;
• Obtaining pricing and reimbursement approval;
• Submitting applications for procurement tenders in accordance with Union and national law, provided this does not involve the sale, offering for sale, or marketing of the product during the patent or supplementary protection period.

 This proposal strengthens the Bolar exemption in two key ways: not only does it clarify its scope but also broadens it to cover participation in tenders and procedures for pricing and reimbursement approvals. It is worth noting that the Council went significantly further than the European Commission in its original 2023 proposal, which did not address participation in public tenders. Such a solution would result in banning a number of persisting forms of patent linkage in the EU.

Next step for the Pharma package

The Pharma Package’s objectives, particularly its aim to increase medicine availability, are highly relevant, and the proposed measures appear to be a positive step in this direction. However, given the complex and lengthy nature of the EU legislative process, it will be essential to monitor the final text closely as it emerges from the trilogues — the negotiations between the Council, the Commission, and the Parliament.