Medicine Shortages - Latest Developments Across Europe
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.
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.
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 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).
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.