Belgian Government Think-Tank Publishes Study on Compulsory Licensing for Expensive Medicines
On 14 June 2022, the Belgian Health Care Knowledge Centre (KCE), a research institute funded by the federal government, published a study discussing “Compulsory Licensing for Expensive Medicines” (the CL Study). The CL Study was commissioned by the Committee for Health and Equal Opportunities of the federal Chamber of Representatives which is reviewing bill 55K407 that seeks to expand the existing system of compulsory licensing for patented medicinal products in the interest of public health (Article XI.38(1) Code of Economic Law).
The publication of the CL Study preceded by a few days the adoption of an intellectual property waiver for Covid-19 vaccines by the Twelfth Ministerial Conference of the World Trade Organisation (see, Van Bael & Bellis Life Sciences News and Insights of 20 June 2022) and was almost immediately welcomed in Parliament by the Minister of Social Affairs and Public Health. While the compulsory licensing of pharmaceutical patents is therefore clearly a trending topic, the CL Study is strikingly cautious in making policy recommendations. This is because compulsory licensing for expensive medicines not only raises questions of principle but also of practical implementation. Additionally, high medicine prices are generally the result of increasingly complex technological innovations.
The CL Study therefore advocates a comprehensive approach that considers the entire regulatory framework, not just patent law, and is in favour of calibrated measures that do not jeopardise the benefits of the current system which seeks to encourage and reward innovation. That is a crucial concern for a country such as Belgium which hosts a thriving ecosystem of pharmaceutical and biotechnological research, development, clinical trials and production facilities. Additionally, the incentives for innovation encompass a range of measures covering patent law, know-how, data and market exclusivity, and targeted rules that stimulate the development of orphan and paediatric medicines. Lastly, the CL Study fully recognises the difficulties associated with defining an excessive price for medicines. It notes that the excessive pricing cases brought by European competition authorities all involve off-patent medicines (for a recent example with regard to Leadiant, see, Van Bael & Bellis Life Sciences News and Insights of 1 June 2022).
On this basis, the CL study makes the following policy recommendations:
- Compulsory licensing should not be an end, but rather a means to bring down prices in exceptional circumstances.
- EU Member States should coordinate any initiatives to impose compulsory licensing in specific cases.
- Adaptations to the current rules governing exclusivity and data access could be envisaged but require careful consideration.
- In Belgium, the exchange of expertise between pricing and reimbursement authorities and the Belgian Competition Authority should be improved.
- There is always scope for a more robust pricing and reimbursement policy and increased cooperation at EU and international level.
- The patent exemption for pharmacists should be optimised.
- Universities and public research institutions should apply “socially responsible licensing conditions”.
- Collaborative models for patent licensing should be encouraged.