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A European task force outlines its upcoming efforts to combat drug shortages.
Editor's Note: This article was published in Pharmaceutical Technology Europe's October 2018 issue.
The European Union is stepping up its efforts to sort out the chronic problem of drug shortages, which has now been a priority for the EU’s medicines agencies for several years. In late August 2018, a joint EU task force on the issue of unavailability of authorized medicines published its work programme for the next two years. The task force was set up in December 2016 by the European Medicines Agency (EMA)-responsible for centrally approved drugs-and the Heads of Medicines Agencies (HMA), which deals with authorizations at the national level.
The programme shows that if all goes to plan, by 2020 the task force will have laid a foundation for a regulatory and supplies management framework that could curb the increasing number of incidents of drugs shortages across Europe. The sudden acceleration in activity on the issue comes as two events loom on the horizon that could cause-temporarily at least-major disruptions to drug supplies.
The biggest of these is Brexit, under which the United Kingdom is due to depart from the EU on 30 March 2019 with the status of a third country independent of the Union’s regulations, including those covering medicines. The UK government revealed in August that it is working with the country’s pharmaceutical sector to stockpile next spring an additional six weeks supply of medicine if the UK exits the EU without a withdrawal agreement. A ‘no-deal’ Brexit with customs barriers being erected between the UK and the remaining 27 EU member states would also impact not only medicines imports from mainland Europe but also the considerable number of medicine exports from the UK to its European neighbours.
The UK and the EU 27 countries seem likely, however, to avoid a no-deal by reaching an agreement this November on measures to soften the regulatory effects of Brexit, including allowing a transition period for a full implementation of the departure by the end of 2020.
Nonetheless, since the country will still legally become a third country at the end of next March, pharmaceutical companies in the UK will have to make regulatory changes, such as transferring quality control activities and the marketing authorization holder (MAH) status of their medicines to a EU state. Small and medium-sized enterprises (SMEs) in the UK are already admitting they may not be able to meet these obligations on time so that the post-Brexit marketing of their drugs in the EU next spring would be illegal.
The other event threatening medicines supplies-although to a lesser extent than Brexit-is the implementation on 9 Feb. 2019 of an EU mandatory scheme for the serialization or barcode identification of individual packs of medicine. The new regulation is being introduced to combat counterfeiting of drugs under the EU’s Falsified Medicines Directive.
There are dangers that the IT infrastructure necessary for the operation of the scheme across the EU may not be fully in place by the deadline. Also, SMEs throughout the EU may have failed to upgrade their packaging lines or arranged to have access to modernized equipment on time.
The EMA–HMA task force, whose members represent the agencies in the EU’s medicines regulating network, is planning to provide a co-ordination and communications platform to deal with any medicine supplies difficulties next spring, particularly relating to Brexit. It is already drawing up its own guidance on the implementation of post-Brexit regulatory changes like MAH transfers.
But the main impetus behind its work programme for the next two years is the need to fulfil the objectives of the five-year year strategy, launched in 2015, of the medicines’ agencies network. Dealing with the lack of availability of authorized medicines is a prime aim of the strategy.
The task force will be guided by a reflection paper of the network, also issued in August 2018, on medicines availability. The paper aims to “provide an oversight of initiatives (and to) propose and explore intended actions to be considered by the network” (1).
The work programme, which is mainly focused on putting into effect actions agreed by the task force in early 2017, covers three main areas: facilitating the authorization and marketing of medicines to minimize shortages, the prevention and management of supply chain disruptions, and the communication of information on availability issues.
The task force’s purpose is to put forward long-term solutions. But what happens to medicines supplies next spring after Brexit and the introduction of the serialization regulation could show that other aspects of the whole issue of drug availability may need to be given equal or even greater importance.
In its new work programme, the task force’s first major job is to complete by the end of 2018 the drawing up of EU-wide common definitions of medicine shortages and what types of specific shortages should be considered to be reportable.
“Until (uniform) definitions are in place we cannot compare shortages/supply disruptions across the EU,” says the reflection paper (1). The paper shows that there is no harmonized definition or approach to the management of shortages in the EU, particularly at the national level. “There is a lack of clarity of what, when, and to whom reports of shortage/unavailability/supply chain disruption should be made,” according to the paper.
The timeframes laid down by the national regulatory authorities for reporting shortages or supply chain disruptions ranges from up to 12 months in some EU states to 96 hours in Belgium and 72 hours in France. At the same time, there are approximately 20 different definitions of shortages in use across the EU, says the paper.
One difficulty facing the task force is that stakeholder groups have different views on what constitutes a shortage. For healthcare professionals and patient representatives, the definition should be determined by how much the lack of availability of a medicine impacts patients. Industry representatives want a distinction between shortages that affect patients and supply disruptions that could be managed with or without regulatory action, according to the paper.
A joint report issued in 2018 by manufacturers, distributors, and health professional associations stressed the importance of a common definition of a suspected medicine shortage (2). This definition would then be used to establish a simple mechanism for assessing a ‘signal’ of a suspected shortage and for deciding whether it is an actual medicine shortage.
It suggested the definition of a suspected shortage as being “the inability for a community or hospital pharmacy, as a result of factors beyond their control, to supply a medicinal product to a patient within a defined period.”
The report emphasized the importance of all suspected shortages being recorded, whether they are single or multisource products.
The reflection paper advises that definitions should consider “availability in a wider sense,” with distinctions, for example, between worldwide non-availability and shortages of a medicine which is available in some EU states but not in others.
By the end of this year, the task force is also due to provide metrics for measuring the extent of shortages so that they can be more easily managed and monitored. Metrics would enable benchmarking of shortages due to causes such as manufacturing problems and distribution difficulties.
Over the next few months, the task force is scheduled to review existing guidance to network agencies on managing shortages, including those that may arise as a result of Brexit. It is also investigating-possibly in preparation for any supply disruptions in the spring-existing ways regulatory agencies communicate to the public information on medicines availability.
Work on other issues in the task force’s programme, scheduled to be finished between next summer and the end of 2020, include matters such as sharing information within the network and setting up single contact points.
In 2019, the task force is tackling potentially thorny questions involving interaction with industry. Guidance for companies on reporting shortages will be completed by mid-2019 and ways of encouraging best practices by industry in preventing shortages will be finalized by the end of next year.
It will be considering ways of introducing authorized medicines into certain national markets that some pharmaceutical companies avoid often because of costs or low returns.
By the end of 2020, it is due to complete work on an initiative on the use of multilingual packages so that medicines with the appropriate translated patient information can be distributed in countries experiencing shortages.
The task force is also scheduled to complete a review in two years of the existing procedures for withdrawals of medicines from markets to enable adequate transition periods for ensuring sufficient supplies of alternative products.
The network’s reflection paper indicates that in the longer term it may be necessary for supply standards to be covered by good manufacturing practice (GMP). This could be done by amending chapter one of the EU GMP guide, which details all matters that individually or collectively influence the quality of a product (1).
MAHs could be required to identify products at risk from potential supply chain disruptions. With medicines deemed to be of critical importance, MAHs may have to draw up plans for preventing shortages. These prevention plans could be the subject of future guidance documents from the agencies network, according to the reflection paper.
The paper warns about the size of the challenge facing the EU. There are a wide range of causes behind shortages, some of which are global in scope, it says. Resolving the problem is going to be a long haul.
1. Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA), ‘’European Union regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use.’’ EMA/565780/2018 (Brussels, 23 Aug. 2018).
2. The European Association of Euro-Pharmaceutical Companies (EAEPC), Medicines for Europe, The European Association of Hospital Pharmacists (EAHP), European Healthcare Distribution Association (GIRP) and four other industry and professional associations. ‘’Joint Supply Chain Actors’ Statement on Information and Medicinal Products Shortages.’’ (Brussels, February 2017).
Pharmaceutical Technology Europe
Vol. 30, No. 10
When referring to this article, please cite it as S. Milmo, "Curbing Drug Shortages in Europe," Pharmaceutical Technology Europe 30 (10) 2018.