Impact of Brexit on Healthcare
After intense negotiations, the European Union (EU) and the United Kingdom opened a new chapter in their relations with the agreement reached on 24 December 2020.
The Trade and Cooperation Agreement (Partnership Agreement) negotiated by the EU and the United Kingdom entered into force provisionally on 1 January 2021 after all 27 member states approved the Agreement and its provisional application. On 27 April 2021, the European Parliament also voiced its approval meaning the Agreement was able to enter into force fully on 1 May 2021. Additional up-to-date information on the agreement can be found on the website of the Federal Foreign Office.
1) How will the Partnership Agreement affect the health sector from 1 January 2021? An overview.
a) The rights of citizens with regard to health and long-term care insurance
Guidance on Brexit for all those affected can be found on the website of the German Liaison Agency Health Insurance – International (Deutsche Verbindungsstelle Krankenversicherung – Ausland) (for example, for tourists, pensioners, students, posted employees). Since the specifics of each case and the questions vary, we recommend that citizens contact their health insurance fund or health insurance carrier in Germany directly./typo3/
Fortunately, in a separate protocol on the coordination of the social security systems, the Partnership Agreement essentially adopts the provisions of Regulations (EC) Nos. 883/2004 and 987/2009 that have applied within the EU to date and also due to the transition period of the Withdrawal Agreement. According to this protocol, the social insurance agencies can continue to apply EU law as if the United Kingdom were still a member state. What can no longer be continued under the Partnership Agreement, however, is the export of long-term care services for new cases, in other words, for situations starting from 1 January 2021 where no cross-border relationship had previously existed between an EU member state and the United Kingdom. Such cases are subject to the new Partnership Agreement, which excludes coordination of long-term care insurance benefits. However, use of the European Health Insurance Card (EHIC) and the Provisional Replacement Certificate (PEB) will still be possible. The recognition of insurance periods will also still be possible. Nevertheless, in some cases, it will be necessary to make healthcare contributions from 1 January 2021 in order to obtain full access to the health care system in the United Kingdom. Persons who are domiciled in the United Kingdom but insured in another country, and students, can under certain circumstances have their contributions reimbursed in part or in full by the United Kingdom. Answers to and tips on health and long-term care insurance can be found in the “FAQs”.
b) Recognition of professional qualifications in healthcare
The Partnership Agreement envisages regulations for the recognition of foreign professional qualifications that will apply to applications for recognition from 1 January 2021. These envisage, in particular, that professional organisations of both contractual partners can propose easing recognition regulations for specific professions if this is in the economic interest of both sides. However, the automatic recognition through the previously valid EU Professional Qualification Directive, will no longer apply. In the absence of eased recognition regulations based on the agreement, from January 2021 EU citizens with qualifications acquired in the United Kingdom must have these recognised based on the regulations valid in Germany for qualifications acquired in third countries. The same applies to British citizens who have not obtained their qualifications in a member state of the EU.
Further information on the recognition procedure can be found at the Information portal of the German government for the recognition of foreign professional qualifications.
c) Movement of medicinal products and medical devices
In principle, the United Kingdom leaves the regulatory system of the EU for medicinal products and medical devices on 1 January 2021. However, the Partnership Agreement establishes, among other things, a foundation for comprehensive economic partnership. At its core, this is based on a free trade agreement that envisages neither customs nor quotas and, as a result, avoids significant barriers to trade. The Partnership Agreement therefore significantly contributes toward ensuring the population's uninterrupted supply of medicinal products, vaccines and medical devices, which remains the Federal Government’s utmost priority. The Partnership Agreement envisages regulations to avoid technical barriers to trade with regard to standardisation and conformity assessment procedures, including medical devices. A highly welcome point, in addition, is the special annex providing possibilities for recognising inspection results in order to certify compliance with Good Manufacturing Practice (GMP certificate) by medicinal products and active substances. On their websites Germany's higher federal authorities draw attention to the potential impact of Brexit and provide information for pharmaceutical companies (BfArM and PEI) Furthermore, on its website EMA provides information for businesses.
d) Health Security
From 1 January 2021, cooperation between the EU and the United Kingdom in the area of health security will take place as with a third country, in other words, only event-driven and on a temporary basis during an acute threat situation – without permanent membership in European structures, as is the case with EU member states or states with a permanent observer status, such as Norway or Liechtenstein. In acute threat situations such as the current pandemic, crisis management corporation with the United Kingdom will continue within the Health Security Committee (HSC) and through the Early Warning and Response System (EWRS) at the European Centre for Disease Prevention and Control (ECDC).
In the area of preparedness planning and crisis prevention, it was possible to secure future collaboration by means of a memorandum of understanding (MoU) with the ECDC, as is the case with other third countries.
2) What applied up to 31 December 2020 during the transition phase?
The transition phase, during which EU legislation on social law coordination and the recognition of professional qualifications in principle still applied, lasted until the end of 2020. As the United Kingdom continued to remain within the EU’s Single Market and the customs union during this time, there were also no changes to the movement of medicinal products and medical devices until the end of 2020.
a) Health and long-term-care insurance
Health coverage, the uptake and billing of health and long-term care insurance services in the respective other country, as well as the recognition of insurance periods, all stayed the same until the end of 2020.
The European health insurance card (EHIC) or the Provisional Replacement Certificate (PRC) for instance, remained valid over this period. Additionally, the Withdrawal Agreement stipulated that people who had already commenced or applied for planned care in the United Kingdom or in Germany before the end of the transition period, would continue to possess the right to pursue that treatment.
From Germany's perspective, health insurance contracts with German private health insurers (substitute health and long-term care insurance as well as state-subsidised supplementary long-term care insurance) signed before the end of the transition period can continue as before if the relevant person was already resident in the United Kingdom on 31 December 2020. The prerequisite for the continuation of a supplementary long-term care insurance with state funding is, however, the eligibility for benefits, in other words, basically, the person to be insured must be a member of the statutory or private long-term care (compulsory) insurance. However, a person can lose this membership if the obligation to be insured ends after 31 December 2020, for example in the wake of a stay abroad without continuation of the insurance or in the case of a “special agreement”, or the insured person cancels his/her private long-term insurance contract, for instance because he/she wishes to switch to the insurance system of the United Kingdom or to a private insurance there. At best, there exists the possibility of signing an entitlement insurance, as long as no need for long-term care and no insurance case has yet occurred. Since individual cases can differ greatly, particularly with long-term care insurance, it is recommended that insured persons consult their insurance companies for further advice.
b) Recognition of professional qualifications
Until the end of 2020, there were no changes with regard to the recognition of professional qualifications in healthcare. Until then, an application for recognition of professional qualifications filed by an EU or UK citizen to a competent authority in the receiving country or country of employment was still determined according to EU rules. The citizens concerned were therefore urged to apply for recognition of their professional qualifications as early as possible and in good time before the end of the transition period. Professional qualifications recognised before the end of the transition period retain their validity within the other country, including the right to exercise the profession on the same terms as nationals.
c) Medicinal products and medical devices
Goods, therefore also medicinal products and medical devices, which were legally placed on the market before the end of the transition period, will retain the right to be traded in the markets of the EU and the United Kingdom after the transition phase until they reach their end consumers, without requiring product changes or renewed labelling.
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. During the transition period, British Notified Bodies were able, in principle, to continue to issue certificates for medical devices and in vitro diagnostic medical devices.
3) Frequently Asked Questions on topics related to health care and long-term care
Questions on the regulations contained in the Partnership Agreement
Questions regarding the Withdrawal Agreement/Old cases
Good to know
Guidance on Brexit for all those affected can be found on the website of the German Liaison Agency Health Insurance – International (Deutsche Verbindungsstelle Krankenversicherung – Ausland).
Since the specifics of each case and the questions asked frequently vary, we recommend that affected citizens contact their health insurance fund or health insurance carrier in Germany directly.
For general information related to health insurance, please contact the citizens’ hotline of the Federal Ministry of Health at: +49 (0)30 3406066 01. A contact form is also available.
Current information, questionnaires and link collections can be found on the website of the Federal Foreign Office.
An overview of Brexit preparations by the Federal Government, the EU Commission and trade associations can be found on the website of the Federal Government.
The EU Commission publishes Questions and answers on the Partnership Agreement.
In addition, the EU Commission has published Guidelines on citizens’ rights in the context of the Agreement on the Withdrawal of the United Kingdom from the EU that, among other things, explain the rules on the coordination of social security systems and the recognition of professional qualifications.
Furthermore, the EU Commission has published a communication as well as, in the meantime, over 80 so-called Readiness Notes in preparation for the ending of the transition periord at the close of 2020. The documents describe legal amendments that stakeholders will have to cater for and which will be necessary in any case at the end of the transition period, irrespective of the outcome of the ongoing negotiations between the EU and the United Kingdom on a future partnership. This applies, among other things, to amendments governing travelling in relation to medical treatment and medical prescriptions, clinical trials, medicinal products, substances of human origin, drug precursors and industrial products including medical devices as well as the area of data protection.