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Sean Milmo is a freelance writer based in Essex, UK.
In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2020 print issue.
The new year looks likely to be one in which the European Union’s medicines regulatory system makes a determined effort to ensure that advances in science and technology result in more innovative medicines being made available to patients in Europe. However, it is also likely to be a year in which regulators will be under even greater pressure to deal more effectively with chronic problems of medicines shortages and quality deficiencies in imported APIs.
It is also projected that 2020 will see the European Medicines Agency (EMA), responsible for the approval of medicines for marketing in the whole of the EU and for the coordination of the drugs licensing network covering the union’s 27 member states, strive to return to a level of normality after two years of disruption. Efforts to regain normality come after the agency’s relocation of its headquarters in 2017 from London to Amsterdam in the Netherlands after the United Kingdom voted to leave the EU in the 2016 referendum.
EMA only formally took over its new headquarters in Amsterdam in January (2020) after initially being accommodated in interim offices in the Dutch city. With the relocation leading to lower staffing levels, the agency has had to considerably curb its activities. It is also trying to cope with a squeeze on its budget at a time of increasing costs.
A major objective in 2020 for EMA will be to return operations to a pre-Brexit level. But with staff numbers being substantially reduced and constraints on its budget that seems to be a difficult task. Instead the agency could end up becoming a slimmer operation focussed on its core priorities of monitoring and evaluating the quality, safety, and efficacy of drugs during their development and throughout their life cycles.
The whole EU regulatory network headed by EMA is answerable to the DG Sante, the health directorate of the European Commission (EC), the Brussels-based EU executive, within which the advisory pharmaceutical committee is exercising a growing influence.
The committee, comprising officials of the commission, EMA, and EU member states, recommended in November 2019 that priority be given to the completion of on-going projects (1). These included action plans on pharmaceuticals in the environment (PIE), improvements in the regulatory environment for advanced therapy medicinal products (ATMPs), antimicrobial resistance (AMR), support for drugs repurposing, and on improving quality of APIs. But the commission itself has just changed its top management with a new president, Germany’s Ursula von der Leyen, and a new agenda, which will generate changes of focus in the pharmaceuticals area.
In healthcare, the new commission has set a number of priorities, such as affordability of medicines and patients’ access to innovative drugs, combatting medicines shortages, encouraging through legislation digitalization in health services, and ensuring the effective oversights of the global supply chain in medicines. In addition, the new commission has launched a European Green Deal to take measures to combat climate change, cut pollution, and help companies develop clean products and technologies (2).
The regulatory agendas of Europe’s medicines agencies at the EU and national levels will be dictated to some extent this year by the commission’s priorities. Among the most important regulatory tasks this year for the EU’s network of medicines licensing agencies will be the finalizing of a strategy covering regulatory science.
A draft EMA strategy on regulatory science to 2025 (3) was the subject of a consultation with a range of stakeholders during 2019, including industry, researchers, healthcare professionals, and patients’ representatives. Regulatory science is seen as a vital platform to fulfilling the mission of the EU medicines licensing network in translating science and innovation into more effective medicines and ensuring that patients have access to them.
“In the pharmaceutical landscape R&D is evolving rapidly, and we, as regulators, must keep pace with it and must be prepared for the future challenges it will present to us,” said Guido Rasi, EMA executive director, at a stakeholders workshop in Amsterdam on the agency’s regulatory science draft strategy in November 2019 (4).
The workshop was held to help in the finalization of the strategy early this year, particularly in sorting out the different priorities put forward by the various clusters of stakeholders taking part in the consultation exercise. The industry representatives in the consultation wanted priority to be given, for example, to novel manufacturing technologies and greater exploitation of digitalization technologies.
The final version of the strategy will be used as a basis for a five-year strategy for the EU’s medicines regulation network (EMRN). This document is due to be drafted by June for publication in October after going through a stakeholder consultation.
EMA and the Heads of Medicines Agencies (HMA) representing the national authorities already have a joint task force on big data identifying how digitalized data sets can be used to develop new and improved medicines (5). This work should provide key components of regulations on digitalization in the medicines sector. But EU regulators face a daunting job in the regulation of areas like data quality and standards for data analytics.
One important consideration is the need for the regulators themselves to have access to skills and training so that they can effectively evaluate the quality of large data sets and the analytics performed on them.
With the EU wanting to be a global leader in using regulation to encourage medicines innovation, it also wishes, through the European Green Deal, to be a pace setter in imposing safeguards on PIE. As a result, PIE tops the list of the current priorities of the commission’s pharmaceutical committee.
Other major objectives, which will be determining regulatory agendas in 2020-and probably much of the rest of the new decade-will be the assurance of secure, efficient, and clean supply chains extending from starting materials, APIs to finished medicinal products.
In 2019, a big threat to these supply chains within Europe was a no-deal Brexit. Under this scenario, the UK-a leading medicines exporter and importer-would be relegated to the status of a third country under EU legislation without the protection even of a free trade agreement (FTA). Both the EU and the UK had to prepare provisional emergency measures to prevent serious medicine shortages due to the sudden introduction of customs checks and quality controls.
However, after the Brexit-supporting ruling Tory party won a UK general election in December 2019 by a substantial majority soon after clinching a withdrawal agreement, the country looks certain to finally leave the EU at the end of January 2020 with trade in medicines and other products remaining relatively intact. Its departure will be accompanied by a transition period of at least a year during which an EU–UK FTA would at least start to be negotiated with the relationship between the two sides staying substantially the same as if the UK were still an EU member.
But the danger of a no-deal scenario will not have been lifted completely. Despite warnings by trade experts that a full FTA will need longer than a year to negotiate, the UK government has indicated that if a trade agreement is not reached by the end of December 2020 it will leave without one, even though there would be an option for extending the transition period to continue negotiations.
The UK could be aiming for a short framework trade agreement with the EU in which regulatory standards, such as those on pharmaceuticals, could be thrashed out over several years. During this time, there would still be a considerable risk of EU–UK trade disruptions and hence medicines scarcities.
Even without the effects of the Brexit dispute, availability of medicines will still remain a major issue in Europe. In recent years, supply chains have been suffering from chronic shortages, particularly stemming from quality issues with APIs, most of which are imported from China and India.
Quality problems worsened with the discovery of nitrosamine impurities, first in late 2018 in Asian-produced APIs for sartan blood pressure medicines and then last year for the diabetes treatment pioglitazone and the ulcer treatment ranitidine. EMA had to ask all relevant pharmaceutical companies to check raw materials and processes in their supply chain for risk of production of nitrosamine impurities, which are classified as probable carcinogens.
Results of an EMA investigation into the episode with ‘lessons to be learned’ are due to be revealed in mid-2020, opening the way to a further tightening up of EU rules generally on checking the quality of imported APIs. Also, this will coincide with a decision by the EMA on the future scope of its operation in the light of a 20% reduction in staffing after its relocation and budgetary restraints.
By the end of the year, not only the rules on imported APIs will likely have changed, but the future of the agency mainly responsible for imposing said rules will have changed as well.
1. Pharmaceutical Committee, Health, Safety, Food Directorate-General, EC, “Work Method and Main Priorities” (Brussels, November 2019).
2. EC, “Communication: The European Green Deal” (Brussels, 11 Dec. 2019)
3. EMA, “Draft European Regulatory Science to 2025 Strategy” (Brussels, December 2018).
4. Guido Rasi, EMA executive director, “Delivering the Strategy,” presentation at Stakeholders Workshop on EMA Regulatory Science (Amsterdam, November 2019).
5. HMA and EMA Joint Big Data Task Force, “Summary Report” (Amsterdam, 13 Feb. 2019).
Pharmaceutical Technology Europe
Vol. 32, No. 1
When referring to this article, please cite it as S. Milmo, “European Regulators Strive to Make Up for Lost Ground,” Pharmaceutical Technology Europe 32 (1) 2020.