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Sean Milmo is a freelance writer based in Essex, UK.
The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.
The European Union’s network of medicines regulating authorities is, for the first time, following a common strategy for at least the next five years in an effort to achieve more consistency and efficiency in the control of pharmaceuticals in Europe. The adoption of the strategy, outlined in a document (1) entitled
EU Medicines Agencies Network Strategy to 2020 and published in December 2015, has been welcomed by Europe’s pharmaceutical industry. But there are divisions within the industry about what should be the strategy’s priorities.
The strategy has been drawn up by the European Medicines Agency (EMA), responsible for regulating medicines for EU-wide marketing, and by the heads of medicines agencies (HMA), which run the decentralized part of the system for the licensing of drugs for single or groups of national markets. The initiative will mean that EMA, which assesses mostly new medicines and biologics, and the licensing authorities of the EU’s 28 member countries as well the three non-EU states of Norway, Iceland, and Liechtenstein, will work much more closely together in the regulation of pharmaceuticals. This strategy will have an impact not just on the control of medicines within Europe, but also globally. The region’s regulatory network will effectively become a single entity representing a population of 500 million, the third largest in the world after China and India.
One key objective of the new strategy is that Europe should have much more clout in the global pharmaceuticals sector at a time when the worldwide harmonization of regulations on the quality, safety, and efficacy of medicines is accelerating. In addition, Europe will be in a stronger position to deal with the growing complexities of the global pharmaceutical supply chain, particularly in the monitoring of manufacturing standards of imported products. Approximately 80% of APIs used in medicines authorized in Europe are now manufactured outside the EU, mostly in India and China, while a significant proportion of medicines on the EU market have been partially or fully manufactured outside the EU, according to the strategy document. One of the 16 main objectives behind the strategy to make better use of the EU’s regulatory network is to ensure that the supply chain of imported pharmaceuticals is properly managed.
Medicines access and drug development
Another major goal behind the five-year strategy is to provide patients with easier access to new and existing medicines, particularly to innovative treatments for unmet needs and rare diseases. Achieving medicines access requires more regulatory resources to be directed at encouraging the development of innovative medicines for the EU market, which will contribute to a vibrant life-science sector in Europe. Nonetheless, representatives of the pharmaceutical industry who are not involved in the development of original, patent-protected products have been complaining that the strategy document puts too much emphasis on innovative medicines without paying enough attention to problems of access to existing treatments. In the 28-page document, there is only a limited reference to the need for regulatory support for a broad range of generics and biosimilars.
“Innovation and scientific progress, being a key pillar of the pharmaceutical industry, shall be supported as much as possible,” said the European Generic and Biosimilar medicines Association (EGA) in comments (2) on the final draft of the document in 2015. “However, access of the majority of the population to essential, first-line quality treatment should not be neglected, but rather, given equal consideration as one of the regulators’ strategic objectives for 2020,” the association added. “Currently more than half of the European population is treated with generic and biosimilar medicines.”
On the other hand, the research-based part of the industry reckons that the strategy does not focus strongly enough on innovation, especially on the need to harness broad support for the development of novel medicines. “Regular initiatives are needed to ensure leverage of knowledge of evolving science between industry, academia, and regulators,” said the European Federation of Pharmaceutical Industries and Associations (EFPIA) in its comments (2) on the strategy. EFPIA explained that the industry is willing to contribute to this pooling of knowledge while also being able to help in the setting of strategic priorities in the innovation process.
Benefits of centralization
Individual member states, most of them fiercely protective of the independence of their medicines regulatory authorities, will be balancing any concerns about the increased centralization inherent in the strategy with the benefits they will gain from it. For authorities in the smaller countries, some of the most important advantages of the strengthening of the network will be greater assistance with the vetting of GMP standards on imported APIs. They will also gain from the expanded capabilities of the network in GMP and other inspections of the production facilities of exporters of pharmaceuticals to Europe.
EMA and HMA are hoping that the network’s efforts to tackle more effectively the causes of medicine shortages and lack of availability of both new and existing pharmaceuticals, particularly as a result of disruptions to the international supply chains, will be a major driving force behind increased collaboration outside Europe. “All regulators worldwide are facing increasing economic constraints, in the context of which international collaboration can provide opportunities to create synergies, avoid duplication, and facilitate work and information sharing,” the document says (1).
Problems in supply chains can be minimized, the document claims, with the help of sharing of information on manufacturing standards so that the same standards can be applied irrespective of production location. The integrity of these data, however, can be undermined by poor training, inadequate attention to accuracy, and occasionally, possible falsification. “The integrity of the data in the studies used to support market authorization is fundamental to trust and confidence in the products themselves,” says EMA and HMA (1).
Pharmaceutical supply chain
Another challenge highlighted in the network strategy is the need to deal with supply-chain problems that, often in the wake of severe disruptions of manufacturing processes, lead to a reliance on a few manufacturers to make one or more essential medicines. A similar dilemma could be posed by outbreaks of infectious diseases requiring the rapid development of vaccines and capacity for their production. The network’s regulators have to be better prepared to deal with such public health emergencies. “Over the next five years, a priority will be to ensure that the network continues to be able to respond to public health emergencies, whether novel infectious diseases or other threats, by facilitating the early introduction of appropriate new treatments or preventative measures,” the document explains (1).
In tackling sudden outbreaks of dangerous infectious diseases and also the growing incidence of antimicrobial resistance, the strategy calls for closer links between human and veterinary medicine in a “One Health” approach covering both humans and animals. Approximately 75% of new diseases affecting humans over the past decade have been caused by pathogens originating from animals or products of animal origin, according to the document (1).
Nonetheless, the need for interdisciplinary collaboration will have to extend beyond human and veterinary medicine. All regulatory authorities in the network will have to ensure that they have the necessary expertise available for dealing with scientific advances that could apply to all medicines, particularly the new ones. There has to be “a clear identification of any gaps in scientific and regulatory expertise [in the network] based on current and future needs,” says the document. If necessary, authorities will have to make more use of others in the network with more expertise. “A more optimal organization of the available expertise across the network should be considered avoiding duplication of work and facilitating enrichment of the expertise through more collaborative working,” it adds.
While striving for greater use of scientific excellence, the network will also aim to reduce the regulatory burden on the pharmaceutical industry and other stakeholders through increased administrative efficiency and cost effectiveness. In reaching this objective, a major role will be played by improvements in the network’s IT services, some of which will be coming from the gradual convergence of national IT systems into an EU IT structure.
The strategy document acknowledges, however, that one dilemma for the network is how to ease the regulatory pressures on industry without hampering moves to higher levels of scientific excellence among regulators. “Initiatives to reduce the administrative burden should go hand in hand with initiatives to further strengthen the output, and in particular, the scientific quality, of regulatory processes during the life span of medicines,” the document stresses. This is only one of a number of major dilemmas facing the network as it endeavours to fulfil its strategic objectives over the next five years.
1. EMA and HMA, EU Medicines Agencies Network Strategy to 2020: Working Together to Improve Health (London, 17 Dec. 2015).
2. EMA, Overview of comments received on EU Medicines Agencies Network Strategy to 2020 (London, 17 Dec. 2015).
Article DetailsPharmaceutical Technology Europe
Vol. 28, No. 2
When referring to this article, please cite it as S. Milmo, "Macro Matters," Pharmaceutical Technology Europe 40 (1) 2016.