On 29th March 2017, the United Kingdom invoked Article 50 of the Treaty of the European Union, and will become a “third country” on the 29th March 2019. Malta relies heavily on the United Kingdom and Ireland for medicinal product supply since medicinal products placed on these markets share a common language. In view of the impending deadline, as well as concerns recently expressed by the European Medicines Agency regarding the potential impact of the current rate of preparation by the pharmaceutical sector for Brexit , it is appropriate to take stock of the current state of affairs for the Maltese pharmaceutical sector.
The Maltese pharmaceutical landscape is dominated by the economies of scale typical of a small island Member State. The “Study on the Availability of Medicinal Products for Human Use” performed for the European Commission in 2012 , clearly indicates the problems of accessibility of medicinal products in small Member States such as Malta. One consequence of this situation is that Malta has made ample use of the provisions of Article 126a of Directive 2001/83/EC, intended to provide an easier route of registration of medicinal products in the interests of public health. The attractiveness of this particular mechanism for Malta is augmented by the fact that the common official language shared with the United Kingdom and Ireland, the two major markets of supply, ensures that there are no adverse consequences to public health with regards to the application, or otherwise, of the Article 63(1) and 63(2), with regards to the provisions for the labelling and package leaflet to be in an official language of the Member State.
The results of these considerations are twofold. First of all, the distribution of types of authorisations to place medicinal products on the market in Malta is atypical – national authorisations account for 2,995 out of a total of 5,408 (55.4%), parallel import licences account for 390 products (7.2%), whilst a considerable 2,023 authorisations (37.4%) are Article 126a authorisations. Indeed, authorisation holders with only national marketing authorisations in their portfolio constitute less than half (46.3%) of all authorisation holders, whilst by contrast just over half of all authorisation holders have Article 126a authorisation in their portfolios, being subdivided into those who only have Article 126a authorisations (29.5%) and those that have both national authorisations and Article 126a authorisations (21.1%). Furthermore, the Government’s Central Procurement and Supplies Unit (CPSU) holds 399 total authorisations – making it the largest single authorisation holder on the island – of which 391 are Article 126a authorisations – 19.3% of the total number of Article 126a authorisations. The need of the Government to intervene and act as the holder of such a significant number of authorisations highlights the important public health role of this type of authorisation.
The second major issue is the considerable number of authorisations where the authorisation holder is either based in the United Kingdom, or where the Maltese authorisation is based on a national authorisation in the United Kingdom. With regards to national marketing authorisations, in 1,051 out of 2,955 marketing authorisations (35.6%), the authorisation holder is based in the United Kingdom and will, at the very least, require a transfer of the marketing authorisation to a holder based in the European Union. It is concerning to note that this figure has changed only very slightly with respect to the figure of 37% reported earlier this year . The slow rate of transfer of these marketing authorisations indicates the very real possibility that, notwithstanding work that may be underway to make the necessary preparations for marketing authorisation transfers, the possibility of a bottleneck being established closer to the deadline date is a distinct possibility.
The situation is even more concerning where parallel import licences and Article 126a authorisations are concerned. 143 out of 390 parallel import licences (36.7%) and 1,290 out of 2,023 Article 126a authorisations (63.8%) are based on national authorisations issued in the United Kingdom, and will therefore become invalid once the United Kingdom is a “third country” with respect to medicinal product legislation. Whilst the possibility that alternative products may not be sourced from elsewhere cannot be excluded, in accordance with European Medicines Agency guidance to assume, and prepare for, a “hard Brexit”, the loss of these Article 126a and parallel import authorisations alone will cause a considerable shift in the public health landscape with regards to the availability of medicinal products in Malta. Indeed the concern is greater if one takes into consideration the fact that out of the 391 Article 126a authorisations held by the CPSU, 370 (94.6%) will become invalid upon Brexit. The situation is further exacerbated if one takes into consideration the fact that the CPSU’s eight non-Article 126a authorisations are all parallel import authorisations sourced from the United Kingdom, which means that in total, 378 of the CPSU’s 399 authorisations (94.7%) will become invalid upon Brexit. These figures have also only shifted slightly since those reported earlier this year , indicating that any efforts to find replacement products have yet to yield the desired results.
The local Medicines Authority is optimising its role within the European regulatory network and maintaining strong working relationships with its UK counterparts in order to mitigate the potential negative effects of Brexit . Nevertheless preparations for the impact of Brexit in Malta will need to take into consideration the latest news both from the United Kingdom, where Health Secretary Matt Hancock recently informed the House of Commons Health and Social Care Committee that preparations for Brexit include options for stockpiling by the pharmaceutical industry, as well as from Ireland, where Taoiseach Leo Varadkar has admitted that similar precautions are under consideration. Moreover, the activities of the local pharmaceutical sector to secure the pharmaceutical supply chain against potential shortages come at a time when stakeholders are already facing considerable challenges in preparing for the impending implementation deadline of February 2019 for compliance with the provisions of the Delegated Regulation (EU) 2016/161 for the safety features appearing on the packaging of medicinal products for human use. A perfect storm is in the making, one that can only highlight the importance of calls, at European level, to ensure that timely actions are taken to ensure the continued and safe access to medicines by patients [5,6].
Prof. Claude Farrugia, Malta EMA identifies gaps in industry preparedness for Brexit, Press Release EMA/445151/2018, 10th July 2018;  Study on the Availability of Medicinal Products for Human Use, Matrix Insight, December 2012;  Shortages which may be caused by Brexit: A Maltese perspective. Presentation by Claude Farrugia at Working Group 3 meeting of COST CA15105: European Medicines Shortages Research Network – addressing supply problems to patients (Medicines Shortages) Action, April 2018;  Interest by the pharmaceutical industry to register medicines through Malta has increased. Malta Chamber of Commerce Enterprise and Industry, February 2018;  Guidelines on the framework of future EU-UK relations. European Parliament resolution of 14 March 2018 on the framework of the future EU-UK relationship (2018/2573(RSP));  United Kingdom Exit from the European Union “Brexit”. Life Science Industry Coalition position paper.