Brexit, What’s Next?

by Jessica Santos | Jul 11, 2016

On June 23, 2016, 52% of UK voters decided to leave the European Union (EU) in a referendum – a vote in which everyone (or nearly everyone) of voting age can take part.[1] Some noted this is a surprising result after months of intense debate and years of a “love, hate and lukewarm” relationship between the UK and EU. The news in the last few weeks is full of Brexit and its impact, but it seems there is no Plan B (what happens after UK leaves), just as there was no Plan A (how to move forward with a split country) either.[2]

Just over a month ago, I wrote a paper on Healthcare Researchers’ Guide to Laws and Regulations.[3] Are these legislations going to change for the UK, and what impact will they have on the EU and the rest of the world?

A short answer is “not much.” The UK is a country that is always active in trade. Not being in the EU doesn’t mean the UK will not trade with the EU.[4] The differences are right to access the single market and what trading agreement they can negotiate with the EU.

From a data protection perspective, the UK’s Data Protection Authority (DPA) – the Information Commissioner’s Office (ICO) – has stressed that the Data Protection Act remains the law irrespective of the referendum result.[5] Implementation of General Data Protection Regulation (GDPR) in the UK will continue, and the UK will still be a member of the EU in May 2018 when the GDPR comes into effect and when exiting the EU. The UK will either be in compliance with GDPR or have to have equivalent data protection standards in place, because in order to transfer data with the EU, one has to prove its data protection “adequacy,” like Canada and New Zealand do. With so many businesses and services operating across borders, international consistency around data protection laws and rights is crucial both to businesses and organisations and to consumers and citizens. The ICO’s role has always involved working closely with regulators in other countries, and that would continue to be the case.

The UK’s competent authority (CA) - Medicines & Healthcare Products Regulatory Agency (MHRA)[6] – has been working with the EU to build single EU portal and database for healthcare researchers to submit to CA.[7] Once completed, the unified portal will accept single dossiers and single submissions in all sites from all EU countries. A new EU safety database will be included in this development to simplify safety reporting, making medicine safety surveillance more efficient and transparent in the healthcare industry. As one of the leaders of this exciting development, the position of MHRA is very clear – regardless of whether the UK is in the EU, UK’s MHRA will continue to collaborate with other EU CAs to bring this EU-based portal online as soon as possible.

The European Medicine Agency (EMA) has announced it would like to underline that its procedures and work streams are not affected by the outcome of the referendum. EMA will continue its operations as usual, in accordance with the timelines set by its rules and regulations.[8]

The UK’s industry associations like the Association of the British Pharmaceutical Industry (ABPI)[9] and the British Healthcare Business Intelligence Association (BHBIA)[10] are always strong industry advocates on safety/pharmacovigilance and the transparency act for antibribery and anticorruption. BHBIA’s adverse events reporting guideline and training[11] and ABPI’s disclosure code and practice[12] are regarded as the industry gold standard and have been adapted by most of the pharmaceutical industry and healthcare research agencies around the world into their internal procedures.

Some other international guidelines and legislations, such as the International Organization for Standardization (ISO), Good Clinical Practice (GCP), Good Engineering Practice (GEP) and Good Pharmacovigilance (GPP), will remain as umbrella regulations for healthcare researchers to observe.

The UK will always be a European country with or without being in the EU. Countries such as Switzerland and Norway who are not in the EU[13] are always included in pan-European studies and are able to attract healthcare research talent and company headquarters. 

We are still in the early stages post-Brexit. Some believe Article 50 of the Treaty of Lisbon[14] will never be invoked,[15] and some argue the next British prime minister may demand early talks with the EU.[16] But as for now, the main regulatory parties related to healthcare research all sent very clear messages – business as usual, collaboration and consistency with the EU will continue.

[1] http://www.bbc.co.uk/news/uk-politics-32810887

[2] https://www.poundsterlinglive.com/economics/5150-why-the-pound-is-so-weakk

[3] http://www.kantarhealth.com/docs/white-papers/healthcare-researchers-guide-to-laws-and-regulations.pdf

[4] http://atlas.media.mit.edu/en/profile/country/gbr/

[5] https://ico.org.uk/about-the-ico/news-and-events/news-and-blogs/2016/06/referendum-result-response/

[6] https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

[7] http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/


[9] http://www.abpi.org.uk/Pages/default.aspx

[10] https://www.bhbia.org.uk/home.aspx

[11] https://www.bhbia.org.uk/guidelines/abpiadverseeventguidelines.aspx

[12] http://www.abpi.org.uk/our-work/disclosure/Pages/disclosure.aspx

[13] http://europa.eu/about-eu/countries/member-countries/

[14] http://www.telegraph.co.uk/news/0/what-is-article-50-the-only-explanation-you-need-to-read/

[15] http://www.theguardian.com/politics/2016/jun/26/who-will-dare-pull-trigger-article-50-eu

[16] http://www.standard.co.uk/news/politics/brexit-exclusive-theresa-may-demands-early-talks-on-britain-leaving-the-eu-a3288141.html

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