Medical devices

If regulation of pharmaceuticals is at one end of a scale (with strict scrutiny of detailed trials before products can be marketed) and the general EU approach for product safety is at the other end (with it being primarily up to manufacturers to ensure the safety of their own products), regulation of medical devices is somewhere in the middle.¹⁴ While the relevant EU legislation has some requirements for initial scrutiny, these are lighter than for pharmaceutical products. Moreover, whereas licensing of pharmaceutical products is undertaken by public bodies (EMA and national agencies), the scrutiny of medical devices is undertaken by private companies that have been designated as “Notified Bodies”

10 European Commission (1989). Transparency Directive 89/105/EEC: transparency of measures relating to pricing and reimbursement of medicinal products. Official Journal, L 40:8.

11 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

12 See European Parliament (2008). Medicinal products for human use: information on products subject to medical prescription. Luxembourg: Publications Office of the European Union. Available at:

http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2008/0256(COD)&l=en, accessed 14 July 2014.

13 For an illuminating account with regard to EU policy-making in this and other sectors, see Passarani I (2019). “Role of Evidence in the Formulation of European Public Health Policies”. PhD thesis, Maastricht University.

14 A good account of the background can be found in Hancher L, Sauter W (2012). EU competition and internal market law in the health care sector. Oxford: Oxford University Press.

(NBs) by the competent authority of the Member State in question. There are around 60 such NBs in Europe.¹⁵

The requirements for marketing medical devices in the EU vary according to the level of risk that different medical products represent. At the low-risk end (class I devices), manufacturers themselves may simply declare that the products meet relevant standards. At the high-risk end (class III devices), NBs must be involved throughout their design and manufacture.¹⁶ However, again unlike pharmaceuticals (and unlike the regulatory regime for medical devices in the United States), medical devices are not evaluated for their safety and effectiveness;

rather, a narrower assessment is made of their safety and whether they function as intended. In practical terms, this means that higher-risk medical devices tend to be authorized more quickly in the EU than in the United States, where clinical trials are required – but also that patients in Europe may thereby be exposed to medical devices with potentially adverse consequences that are not brought to light by the more limited assessment required.¹⁷ Doubts have also been expressed about the role of NBs in the regulatory process; as private companies whose income derives from the fees that they charge manufacturers, NBs face a contradictory set of objectives, balancing the need to fulfil their obligations with the need also to continue to receive approvals business from manufacturers.

There is also a serious lack of data about how effective the controls are in practice, with a lack of public access to data about product licensing or adverse events.¹⁸ In November 2018 a global investigation known as the “Implant files” revealed the harm caused by medical devices that had been poorly tested in Europe.¹⁹ One significant scandal concerns defective breast implants, known as PIP implants.

Manufactured by a French company and marketed in 65 countries around the world, they were available for over a decade with official authorization despite multiple warnings from physicians and despite the fact that the Food and Drug Administration (FDA) had banned these implants from the US market as early as 2000. In total, more than 400 000 women in 65 countries received these implants. On 30 March 2010 the then French Health Products Security Agency (AFSSAPS) announced the recall of PIP implants due to their unusually high rupture rates, combined with the (re)discovery that the manufacturers had been deliberately using unapproved industrial silicone since 2001 in order to save

15 Medtech Europe (2019). Industry Perspective on the Implementation Status of the MDR/IVDR. Available at: https://www.medtecheurope.org/wp-content/uploads/2019/06/2019_MTE_MedTechEurope-IVDR-MDR-Implementation-Status-07-June-2019.pdf.

16 Chai JY (2000). Medical device regulation in the United States and the European Union: a comparative study. Food and Drug Law Journal, 55:57.

17 Kramer DB, Xu S, Kesselheim AS (2012). Regulation of medical devices in the United States and European Union. New England Journal of Medicine, 366(9):848–55.

18 Kramer DB, Xu S, Kesselheim AS (2012). How does medical device regulation perform in the United States and the European Union? A systematic review. PLoS Medicine, 9(7):e1001276.

19 https://www.icij.org/investigations/implant-files/.

money. As ever, crises have a way of driving change, and the Commission has proposed some strengthening of the oversight for medical devices, in particular following serious problems involving these faulty breast implants, vaginal mesh and some hip replacements.²⁰

In 2017 the EU passed two new laws intended to address the deficiencies in medical devices regulation.²¹ They are intended to be fully effective in 2020 and 2022, replacing the three previous directives on medical devices. The new regulations address some of the weaknesses of the EU regulatory system. First, they seek to increase the transparency of the system through the collation of key supply chain data. The 2017 regulations therefore expand the EU’s existing centralized database (EUDAMED) to collect new data on vigilance and post-market surveillance in a form that is supposed to be interoperable with centrally held clinical trials data on pharmaceuticals.²² Second, the directives also require the creation of a central register of supply chain operators and NBs, as well as the centralization of serious incident reports. Regarding patients, implant recipients will now get “implant cards” describing the type of implants they received.

Third, the EU Commission can now investigate when an NB does not seem to be fulfilling its function properly. At the national level, health agencies can conduct unannounced visits and NBs must submit documentation upon request.

Finally, national agencies can control an NB’s assessment of a manufacturer’s documentation before the device is placed on the market.

Although these reforms represent significant improvements to the previous regulatory framework, some components might not be implemented and some key issues are left unaddressed. Industry representatives have raised strong concerns that the timetable for adapting to the new regulations is too tight. As of July 2019, of the approximately 60 NBs in the EU only two had been approved for NB status under the new regulations. Concerns have also been raised about whether or not the EU will deliver on the full promise of EUDAMED due to technical difficulties as well as predictable political difficulties.²³ Failing to approve enough NBs would result in significant consequences for patient access to medical devices across the EU, while a subpar EUDAMED would significantly weaken the impact of the directive on patient safety.

20 European Commission (2012). Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals (COM(2012)540 final). Luxembourg: Publications Office of the European Union.

21 Regulation 2017/745 on medical devices (EU IVDR) and Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR).

22 McHale JV (2018). Health law, Brexit and medical devices: a question of legal regulation and patient safety. Medical Law International, 18(2–3):195–215.

23 Medtech Europe (2019). Industry Perspective on the Implementation Status of the MDR/IVDR. Available at: https://www.medtecheurope.org/wp-content/uploads/2019/06/2019_MTE_MedTechEurope-IVDR-MDR-Implementation-Status-07-June-2019.pdf.

Vitally, under the new directives NBs and supply chain operators remain almost entirely responsible for pre-market control. The pre-2017 frameworks remain, in that respect, largely intact, despite the fact that states lack the capacity to effectively control the actions of NBs. Finally, although the EU Commission originally proposed a more centralized system analogous to that embodied by the EMA or the FDA, private actors and NBs lobbied against it.²⁴ Taken together, both regulations maintain – and only marginally improve – a dangerous situation, which resulted in the past in poor health outcomes for patients receiving defective implants.

4.1.3 Pharmacy

Pharmacies and pharmacists receive much less attention in European policy debates than pharmaceuticals, but it is worth noting the complexity and importance of the field (independent of the issue of drug pricing, and parallel trade which we do not cover²⁵). “Pharmacy” means many different things in different countries, and there are often strict rules regarding their locations, hours, ownership and staffing. There has been a long series of challenges to these regulations as contraventions of the freedom to provide services, e.g. from firms that wanted to sell online prescriptions across the EU. The Court, so often open to that kind of deregulatory challenge to apparently discriminatory national policies, has been much less open to them in the case of pharmacy.²⁶

4.2 People

A commitment to the mobility of people has been a preoccupation of the EU for as long as there has been an EU: at its inception, Italy was concerned to ensure that its citizens could work in the prosperous coal fields of Belgium and West Germany, and fought for strong free movement provisions that would allow them to do so.²⁷ In health, today, there are three major issues in the free movement of people. The first is the biggest: the movement and regulation of the healthcare

24 Hervey TK, McHale JV (2015). European Union Law: Themes and Implications. Cambridge: Cambridge University Press.

25 For a starting point in the public health politics of drug pricing, see Hancher L (2010). “The EU pharmaceuticals market: parameters and pathways”, in Mossialos E et al. (eds.). Health Systems Governance in Europe. Cambridge: Cambridge University Press, pp. 635–82; Jarman H, McKee M, Hervey TK (2018).

Health, transatlantic trade, and President Trump’s populism: what American Patients First has to do with Brexit and the NHS. Lancet, 392:447–50. For a valuable political analysis that has not dated much, see Permanand G (2006). EU pharmaceutical regulation: the politics of policy-making. Manchester: Manchester University Press; and Permanand G, Mossialos E (2005). Constitutional asymmetry and pharmaceutical policy-making in the European Union. Journal of European Public Policy, 12(4):687–709.

26 For a relatively critical but thorough and lucid analysis of the pharmacy cases to 2011, see Hancher L, Sauter W (2012). EU competition and internal market law in the health care sector. Oxford: Oxford University Press.

27 Maas W (2007). Creating European Citizens. Lanham, MD: Rowman & Littlefield.

workforce within Europe. The second is the movement of patients under social security law, the long-established mechanism for patient mobility that includes the EHIC card. The third deals with migration in and out of the EU itself. In health and in general the movements of the workforce, of consumers and of third country nationals (non-EU citizens) are very different issues.