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Sean Milmo is a freelance writer based in Essex, UK.
A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s October 2019 print issue.
The new Brussels-based European Commission, which is due to take over in November 2019, will be playing the powerful role in the European Union of putting forward legislation, which must be approved by the parliament and the council of ministers representing the governments of member states, soon to be reduced to 27 with the departure of the United Kingdom.
The commission will also have a key role in drawing up EU-wide strategies not just in the economic sphere but also the social field, including health. Environmental issues, such as climate change, are being considered at the EU level from an economic and social policy standpoint. The Finnish government has pledged to promote wellbeing during its current six-month presidency of the council of the EU on the grounds that wellbeing is an EU responsibility and is at the core of its raison d’être (1).
Authorization of pharmaceuticals is no longer just a matter of ensuring an open, barrier-free market in medicines but is also an instrument of social policy covering areas such as the right to effective healthcare. In fact, certain EU political and social groups believe that social policy should now be given top legal priority so that in the judgments of the European Court of Justice (ECJ) it would be given prominence over purely economic factors (2).
Ursula von der Leyen, a German politician, who has been appointed by EU leaders to be the president-elect of the new commission, has already indicated that she wants the body to be more active in healthcare affairs than its predecessors (3). This could result in stricter controls on pharmaceuticals but could also encourage more innovations in medicines and their production processes. Her healthcare focus was confirmed by her decision to move all responsibilities for pharmaceutical-related activities to the commission’s health directorate-DG Health and Food Safety.
The directorate will, for example, take over implementation of regulations for medical devices, including drug–device combinations (DDCs), from the commission’s industry and internal market directorate DG Grow (4). Responsibilities for pharmaceutical-related biotechnology and the food supply chain will also be transferred from DG Grow to the health directorate (4). The accountability to the commission of the European Medicines Agency (EMA) will be centralized more clearly within DG Health (4). As a result of all these changes, the commission’s duties for the instigation and implementation of pharmaceutical regulations, as well as enacting medicines-linked public health policies, will be concentrated within a single directorate.
The appointments of von der Leyen and her designations of 26 commissioners still have to be approved by the European Parliament. But it is unlikely that the membership of the new commission or the agenda put forward by its president-elect will be radically changed.
Among the first initiatives on medicines legislation by the new commission could be sorting out difficulties with the authorization of DDCs under a new medical device regulation (MDR), which is due to come into force in 2020 (5). “I want you to focus on the effective implementation of the [MDR] to protect patients and ensure it addresses new and emerging challenges,” von der Leyen told Kyriakides in a letter (5).
The MDR may need to be modified to clarify the role of pharmaceutical agencies in the authorization of DDCs, particularly with respect to quality standards. Medicines authorities have the job of assessing the quality and safety of the drug in the DDC, while certification organizations, called notified bodies (NBs), judge the quality and safety of the device component (6).
In the current text of the MDR or its guidelines there is a blurring of the responsibilities of medicines agencies and NBs in assessing the interaction between the drug and device in a DDC, particularly with single non-reusable integral products such as pre-filled syringes or autoinjectors (7). Pharmaceutical companies have also been complaining about a lack of clarity in what information they are required to give NBs and vice versa.
Another worry is that an insufficient number of NBs will have been designated by the EU to conduct MDR assessments when the new regulation, which replaces a 1993 piece of EU legislation, is due to be implemented in May 2020 (8). Certification organizations have to meet tougher criteria to be chosen as NBs under the MDR, which has aroused fears that many will fail the selection process. Only about half the required number could be in operation by the end of this year, according to MedTech Europe, the medical devices trade association (8).
Once chosen, NBs will find that the MDR assessment of products will take longer than under previous legislation because the scope and number of quality, safety, and performance requirements has been increased. Re-certification of an existing product could take up to nine months and even longer in cases of new products (8).
The pharmaceutical and medical device sectors are warning that after MDR is scheduled to come into force in 2020 large numbers of products may have to be taken off the market while the launch of many new ones will have to be postponed because they will be non-compliant (8). This will be at a time when a growing proportion of medicines are being introduced as DDCs because of their greater convenience and effectiveness.
Among the other tasks set by von der Leyen for the health directorate is greater use of Big Data and digitalization to promote health data exchange and research on preventive strategies as well (5). Also, ways should be explored to ensure that Europe has sufficient supplies of affordable medicines to meet its needs. “The pharmaceutical industry (should be supported) to ensure it remains an innovator and world leader,” said von der Leyen.
Another assignment for the directorate is the putting forward of a ‘Europe’s Beating Cancer Plan’ to help member states improve cancer prevention and care (5). This should propose actions to strengthen the EU’s approach at every key stage of the disease-prevention, diagnosis, treatment, life as a cancer survivor, and palliative care.
Perhaps under the new commission, DG Health’s top priority will be the fight against antimicrobial resistance (AMR) through the full implementation of the European One Health Action Plan against AMR covering human, animal, and environmental health (5). “Many of today’s epidemics are linked to the rise or return of highly infectious diseases,” said von der Leyen.
The importance given by the new commission to the enforcement of the EU’s One Health Action Plan is strongly supported by the pharmaceutical industry. “Tackling one of the great public health challenges of our time requires collaboration,” Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said in a blog in September 2019 in response to von der Leyen’s call for action (9).
“The One Health approach demands collaboration between the human, animal, environment, and food sectors to address this complex shared problem,” Moll continued. “That’s why, together with 16 organizations active in human and animal health, we have called for AMR to be at the forefront of EU inter-institutional discussions.”
Health campaigners want the One Health Action Plan to be broadened in scope. “This plan lacks concrete targets, so we call on the EU to set targets which are measurable and ambitious,” an 18-strong alliance of healthcare non-governmental organizations (NGOs) and patient groups declared in a statement in April 2019 (10).
Some NGOs have been urging pharmaceutical manufacturers to do more to curb AMR by eliminating it from wastewater discharges from their antibiotics plants. In fact, leading producers of antibiotics are already taking steps to curb antibiotics discharges from their plants. In a survey of international research-based and generic antibiotic manufacturers, the Amsterdam-based Access to Medicine Foundation revealed that 15 out of 18 research-based companies had some form of environmental risk-management strategy aiming to minimize the impact of antibiotic discharges (11). Six of these companies-GSK, Johnson & Johnson, Novartis, Pfizer, Roche, and Sanofi-were the best performers, applying their environmental risk-management strategies not only to their own manufacturing sites but also those operated by third-party manufacturers of APIs and drug products.
The foundation is using data from its surveys to develop a benchmark on anti-AMR actions by pharmaceutical companies to help governments in drawing up procurement policies for medicines. However, even the best performing producers have been reluctant to disclose details of their activities with antibiotic discharges, in particular the metrics they use to put limits on discharges and whether these have been exceeded.
AMR is probably the area in healthcare where the new commission has the opportunity to achieve the most success because of the amount of backing throughout industry for action. But it will be a tough job.
1. EU2019FI, “A Competitive and Socially Inclusive EU,” accessed 30 September 2019.
2. ETUC, “Protocol on the relation between economic freedoms and fundamental social rights in the light of social progress” (Brussels, 18 March 2018).
3. U. von der Leyen, “A Union that strives for more. My agenda for Europe,” ec.europa.eu (Brussels, September 2019).
4. EC, “European Commission 2019–2014-Allocation of portfolios and supporting services” (Brussels, 10 September 2019).
5. EC, “Ursula von der Leyen, President-elect European Commission: Mission letter Stella Kyriakides, Commissioner-designate for Health” (Brussels, 10 September 2019).
6. EMA, “Medical devices” (Amsterdam, June 2019).
7. EBE and EFPIA, “An Industry Perspective on Article 117 of the EU Medical Devices Regulation and Impact on how Medicines are Assessed,” Reflection Paper (Brussels, 12 July 2018).
8. MedTech Europe, “Industry Perspective on the Implementation Status of MDR/IVDR” (Brussels, 14 June 2019).
9. EFPIA, “EFPIA is Ready to Answer EU’s Call for Action on Antimicrobial Resistance,” Blog (Brussels, 19 September 2019).
10. EU4Health, “Joint position: Europe, let’s do more for health!” (Brussels, April 2019).
11. AMR Benchmark, “B Manufacturing and Production,” Research Areas, accesstomedicinefoundation.org, 13 December 2018.
Pharmaceutical Technology Europe
Vol. 31, No. 10
When referring to this article, please cite it as S. Milmo, “Out with the Old and In with the New European Commission,” Pharmaceutical Technology Europe 31 (10) 2019.