Impact of Brexit on the healthcare system
What will change for citizens in terms of healthcare and long-term care if the United Kingdom leaves the EU? Here you will find information on health and long-term care insurance and coverage in case of illness or long-term care needs, on the recognition of professional qualifications in healthcare and on the movement of medicinal products and medical devices, both in the case of an unregulated Brexit and that of a regulated Brexit.
Within the Federal Government, the Federal Ministry of Health is responsible for three areas in the Brexit negotiations:
Citizens' rights with respect to health and long-term care insurance or coverage in case of illness and long-term care needs
Following Brexit, the EU regulations on social security coordination (EC) 883/2004 and 987/2009 as well as the Directive on Patients' Rights in Cross-border Healthcare (Directive 2011/24/EU) will no longer apply to the United Kingdom of Great Britain and Northern Ireland (hereafter UK). In certain cases, this will lead to problems in maintaining and accessing health care coverage in case of illness, in the uptake and billing for reimbursement of health and long-term care insurance services in the other country, as well as when recognising insurance periods.
Information offered by the German Liaison Agency Health Insurance – International (DVKA)
Questions and answers for employed persons and insured members of the German statutory health insurance and long-term care insurance funds residing in Great Britain, as well as persons hitherto insured with the National Health Service (NHS) residing in Germany, can be found on the website of the German Liaison Agency Health Insurance – International (Deutsche Verbindungsstelle Krankenversicherung – Ausland, DVKA).
The Federal Ministry of Health therefore welcomes the fact that, in November 2018, the negotiators of the United Kingdom and the EU-27 have reached a political Withdrawal Agreement in the exit negotiations that can ensure comprehensive protection of existing rights and legitimate expectations. The agreement allowed EU/UK citizens living in the UK/EU (as well as their family members), to continue living, working, studying and having access to or the possibility to coordinate social security benefits, even beyond the transition phase (until the end of 2020, one extension possible until the end of 2022 at the latest). In this case, the statutory health and long-term care coverage would continue to apply unchanged for EU citizens living in the UK (as well as for those moving to the UK before the end of the transition phase) and their relatives. From a German perspective, health insurance contracts signed with German private health insurers (substitute health and long-term care insurance) by people already residing in the UK up to the time of the Brexit may continue as before. Since individual cases can differ greatly, particularly with long-term care insurance, it is recommended those insured turn to their insurance companies in case of doubt.
Despite the political agreement, a disorderly exit without a Withdrawal Agreement cannot be excluded by the EU or the UK up until the end of the ratification process. The Federal Government is therefore also making preparations to hedge against the possibility of a disorderly Brexit and has passed a law with provisions pertaining to the coordination of social security schemes (health, long-term care, accident, pension and unemployment insurance), which was announced in the Federal Law Gazette on 11 April 2019. This law will help avoid undue hardships due to the cessation of EU law, providing coverage for people in the UK who are members of the German statutory health and long-term care insurance in case of illness or long-term care as well as those thinking about returning to Germany following Brexit. This law will provide short-term legal certainty with regard to insurance status, claims and services and will only come into effect in case of a disorderly Brexit without a Withdrawal Agreement.
Recognition of professional qualifications in healthcare
When the transition phase ends or (in case of a disorderly Brexit) upon withdrawal, the Professional Recognition Directive 2005/36/EC will no longer apply to the UK, which means the regulations contained therein pertaining to the automatic recognition of professional healthcare qualifications of doctors, dentists, pharmacists, midwives, nurses and health workers may no longer be applied between the UK and the EU.
The Withdrawal Agreement makes provisions for grandfathering. This means that the professional qualifications of an EU or UK citizen and his/her relatives, recognised by the receiving country or country of employment before the end of the transition phase on 31 December 2020, shall retain its validity within that country, including providing the right to exercise the profession on the same terms as a national. An application for recognition of professional qualifications by an EU or UK citizen to a competent authority in the receiving country or country of employment before the end of the transition phase, as well as the corresponding decision, will still be determined according to EU rules.
Should it not come to a Withdrawal Agreement but instead to a disorderly Brexit, then any professional qualifications by EU or UK citizens that were recognised before the exit date in the receiving country or the country of employment shall retain their validity therein. In the case of a disorderly Brexit, to be professionally recognised in Germany, British degrees completed following Brexit would be subject to the same general rules of recognition as for nationals of third countries. It is uncertain whether professional qualifications of EU citizens in health professions will be recognised in the UK, since this will depend on the UK's national regulations.
The citizens concerned are therefore urged, irrespective of whether or not an agreement is reached, to apply for recognition of their professional qualifications as early as possible and before the withdrawal date or the end of the transition phase.
Movement of medicinal products and medical devices
Ensuring the population's uninterrupted supply of medicinal products, vaccines and medical devices is of utmost priority for the Federal Government.
According to the Higher Federal Authorities within the remit of the Federal Ministry of Health, there is currently no concrete evidence that the United Kingdom's withdrawal from the EU will lead to serious problems with the supply of medicinal products or vaccines in Germany. Losing the contribution of the British licensing authority (MHRA – Medicines and Healthcare products Regulatory Agency) to handling the workload resulting from European authorization procedures and approval procedures for clinical trials, means that the authorities of the other Member States, such as the German licensing authorities BfArM and PEI , will need to take over an increasing number of their tasks. Provision has already been made for increasing their staff accordingly.
Should it be possible to reach a Withdrawal Agreement with a transition phase until the end of 2020, then goods, which were legitimately placed on the market before the end of the transition phase, will preserve the right to be traded in the UK and EU markets after the transition phase.
Even in the event of disagreement, at this point in time BfArM and PEI assume it will be possible to avoid major bottlenecks in supplying patients with medicinal products. It will be crucial, however, that the pharmaceutical companies concerned take the necessary measures into their own hands and in timely fashion. On their websites, Germany's higher federal authorities draw attention to the potential impact of Brexit and provide information for pharmaceutical companies. In addition, the EMA has also posted Brexit-related information for companies on its website.
Medical devices and in vitro diagnostic medical devices
Depending on the risk class of a medical device or an in vitro diagnostic medical device, manufacturers must work together with a Notified Body when pursuing the conformity assessment of their device.
Should it be possible to reach a Withdrawal Agreement with a transition phase until the end of 2020, then goods, which were legitimately placed on the market before the end of the transition phase, will preserve the right to be traded in the UK and EU markets after the transition phase. During this transition phase, British Notified Bodies would be able to continue to issue certificates for medical devices and in vitro diagnostic medical devices.
However, the situation would be different in the event of disagreement. Since Notified Bodies must be based in a Member State of the EU, and must be designated by a Designating Authority of a Member State, British Notified Bodies will lose their status as EU Notified Bodies should a disorderly Brexit occur. However, a certificate from an EU Notified Body is necessary for a medicinal product or an in vitro diagnostic medical device to be placed on the European and/or German market. Consequently, manufacturers are under obligation to assume responsibility for seeking a Notified Body and, where necessary, an authorised representative in the EU27 and fulfilling the registration obligations, so as to be able to continue to lawfully place their devices on the market in the EU27. According to information from the competent British authority, the MHRA, there will however be a large number of ‘British’ certificates that can no longer be transferred to an EU27 Notified Body in time until UK leaves the EU. The supply situation for medical devices and in vitro diagnostic medical devices on the German market, too, will therefore depend decisively on whether and when the competent authorities of the Member States are able to agree on a joint procedure for dealing with the manufacturers and devices that have been granted certificates by a British Notified Body, which cannot be transferred to an EU Notified Body by the exit date. The Federal Ministry of Health is actively involved in the discussions taking place within the relevant European bodies. To support this position, the Federal Minister of Health Jens Spahn submitted concrete proposals for solutions to the EU Commission on 27 March 2019 and requested the latter’s support.
For further information, please refer to the publications of the European Commission regarding EU provisions on industrial products.
On 10 April 2019, the European Council (Art. 50) unanimously and in agreement with the UK Government extended the deadline for withdrawal under Article 50 until 31 October 2019. The aim is to give UK policymakers more time to create clarity on important questions concerning adoption of the Withdrawal Agreement and the nature of the future relationship.
In its Conclusions, the European Council underlined that the UK must take part in the European elections in May if it is still a member of the EU at this time. Should the UK fail to uphold this obligation and does not hold elections, it will automatically leave the EU on 1 June 2019.
Furthermore, the European Council reiterated that the Withdrawal Agreement will not be reopened, but simultaneously emphasised its willingness to adapt the Political Declaration under certain circumstances if the UK so desires. There can be no negotiations on future relations during the extension to what is known as the Article 50 deadline.
Finally, the European Council underlined its clear expectation that the UK adhere to the principle of loyal cooperation and in particular that it does not impede the EU’s further development.