Insights & news

MEP Cindy Franssen Raises Important Questions Regarding Medicine Shortages in European Union

  • 10/01/2020
  • Articles

Member of the European Parliament Cindy Franssen submitted to the European Commission (the “Commission”) a series of interesting questions regarding medicine shortages (see, attachment). Broadly, the questions probe for (i) possible violations of Directive 2001/83/EC if pharmaceutical firms “caus[e] shortages [of medicines] on the basis of commercial decisions”; (ii) the measures which the Commission plans to take to tackle shortages; and (iii) the proposals which the Commission intends to put forward in order to enhance local production of medicines.
 
While some of these questions exhibit bias against the pharmaceutical industry, they are likely to prompt important answers from the Commission in relation to (i) the public service obligation associated with supplying medicines as contained in Article 81 of Directive 2001/83/EC; (ii) the initiatives which the Commission will take to address medicine shortages (see, Van Bael & Bellis Life Sciences Newsflash of 26 November 2019 and Van Bael & Bellis Life Sciences Newsflash of 11 September 2019); and (iii) calls made in various circles to make sure that the production of key pharmaceutical ingredients is moved to Europe (see for example, Van Bael & Bellis Life Sciences Newsflash of 9 July 2019).

 

Attachments:

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 14/01/2020
    • Articles

    OECD Makes Recommendations for Improvement of Performance-Based Managed Entry Agreements for Medicines

    The Organisation for Economic Co-operation and Development (“OECD”) published a health working paper (the “Paper”) authored by Martin Wenzl and Suzannah Chapman that offers recommendations for the use of performance-based managed entry agreements in OECD countries and EU Member States (see, attached). The Paper reflects the results of a review of managed entry agreements (“MEAs”) carried out in 2018 and 2019. MEAs are arrangements between healthcare payers and pharmaceutical firms that provide for the reimbursement of generally new health technologies, including medicines, while controlling the financial impact of that reimbursement and keeping price concessions confidential. These financial agreements are thus tools for achieving patient access to medicines while managing uncertainty. A further group of MEA’s, far less common than these purely financial agreements, are performance-based contracts. Both financial MEA’s and performance-based MEA’s can be assessed either at the level of individual patients or at that of a given population. The Paper indicates that the experience with performance-based MEA’s is both limited and mixed. This is in large part due to the dearth of available information as few countries have formally assessed their experience with performance-based MEA’s. The Paper therefore relies on limited public sources and a number of expert interviews. Only Belgium and Sweden had independent evaluations conducted by third parties. The tentative conclusion of the Paper is that performance-based MEA’s have made only a limited contribution towards reducing uncertainty regarding product performance. This is why the Paper makes recommendations for good practices that make it more likely for performance-based MEA’s to reach their objectives. These are: i. to use performance-based MEA’s strategically and in the wider context of information derived from the use of other instruments such as horizon-scanning; ii. to identify uncertainties and design the performance-based MEA’s to address such uncertainties; iii. to create a governance framework that ensures transparency of process and guarantees that results are actually acted upon; iv. to ensure an appropriate level of transparency of content, even though some parts of the MEA’s, such as prices, may have to remain confidential. The Paper points out that countries could benefit from sharing information but very little information is at present published or shared. Still, the Paper cites approvingly a number of collaborative initiatives of the European Medicines Agency such as the EU-wide framework on patient registries or the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

    Read more
    • 13/01/2020
    • News

    Brussels Court of Appeal Confirms Infringement of Competition Rules by Professional Organisation of Pharmacists but Directs BCA to Recalculate Fine

    On 8 January 2020 the Market Court of the Brussels Court of Appeal confirmed a finding of the Belgian Competition Authority (“BCA”) that the professional organisation of pharmacists had infringed the competition rules. However, it also directed the BCA to recalculate the fine which is now expected to turn out significantly lower. Please find attached a note on the judgment as well as its text.

    Read more
    • 06/01/2020
    • Articles

    Grand-Duchy of Luxembourg - Creation of National Medicines Agency

    The Council of Government of the Grand-Duchy of Luxembourg approved on 20 December 2019 a draft bill that provides for the creation of a national medicines agency which will be known as "Agence luxembourgeoise des médicaments et des produits de santé" (« ALMPS ») (see attached press release). As its name suggests, ALMPS will be responsible for a range of products, including pharmaceuticals, medical devices, cosmetics, food supplements and other health products. As a result, Luxembourg will cease to be one of the few European countries without a medicines agency that is separate from the executive branch of government. According to the press release, once operational, ALMPS will be in a better position to cope with a range of public health issues, including health risk management, medicine shortages and universal access to medicines. Additionally and significantly, ALMPS will also be given an economic remit in that it will facilitate and preserve investment in the life sciences sector (the press release expressly mentions the biotechnology industry). ALMPS is supposed to achieve that goal by creating legal certainty in the form of a regulatory framework which will be “precise” and “administered efficiently” and will govern activities such as production, commercialisation and clinical trials.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *