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Medicine Shortages - Latest Developments Across Europe

  • 18/11/2019
  • Articles

Medicine shortages remain a high-priority issue for governments across Europe. During the last few days, a new slew of measures and policy initiatives emerged.
 
Norway
 
On 7 November 2019, Norway notified to the European Commission (the “Commission”) proposed powers that would enable the Norwegian Medicines Agency to prohibit medicine wholesalers from making parallel exports of specific medicines if their continuous supply in Norway is at risk (see, attached notification). The notification is based on Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services. This Directive also applies to the EFTA countries, including Norway, and allows the Commission, EU Member States and EFTA countries to offer their view on the compatibility of the proposed measures with European pharmaceutical law and with the free movement of goods principle. In this case, the consultation period runs until 10 February 2020.
 
Norway stresses that medicine shortages form a growing problem of international dimensions in the face of which small countries such as Norway are nearly powerless. According to Norway, a tailored export prohibition on wholesalers is one of the few adequate and proportionate instruments available to protect the health of the local population.
 
Portugal
 
In Portugal, the Portuguese medicines agency Infarmed published new rules to manage medicine shortages (see, attached rules). They come in the wake of recent statutory powers that sought to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. (see, Van Bael & Bellis Life Sciences Newsflash of 23 August 2019). Wholesalers must have at least one month’s worth of supplies, while medicine suppliers must ensure two months’ worth of supplies. Suppliers, wholesalers and pharmacies are required to notify the authorities of shortages within 24 hours of becoming aware of the issue, while suppliers with advance knowledge of an emerging shortage issue should notify the authorities at least two months ahead of the shortage.
 
Belgium
 
Belgium has taken a number of practical steps to confine the problem by creating an interagency database for medicines subject to shortages, intensifying the channels of communication between the supply chain stakeholders and generally raising awareness of the existing rules and obligations. At the same time, the Constitutional Court struck down a law limiting parallel exports of medicines as inadequate and incompatible with EU free movement principles (see, Van Bael & Bellis Life Sciences Newsflash of 17 October 2019).
 
As a result, there would seem to be a groundswell of opinion in favour of further measures tackling medicine shortages. For example, a number of members of parliament advocate for higher fines to be imposed on medicine suppliers that fail to comply with existing obligations. Additionally, tighter supply obligations are also under consideration. Meanwhile, the caretaker government is also understood to work on a draft Royal Decree.

Medicine shortages are now a politically charged subject and this is illustrated by the lengthy report which the chamber of representatives of the federal parliament just made publicly available. The report covers three hearings on medicine shortages which took place over the last few months before the parliament’s committee on health and equal opportunities (see, attached report).  
 
Europe

Even though the incoming Commission will not take office until 1 December 2019 at the earliest, it now looks certain that medicine shortages will be high on its healthcare agenda. As a first step, officials of Directorate General SANTE have reportedly already earmarked a study that would look at harmonised rules governing supply obligations, notifications of shortages and monitoring systems. A further study would analyse parallel trade and market withdrawals.

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    • 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.

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    • 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.

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    • 10/01/2020
    • Articles

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

    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).

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