BREXIT EFFECT ON U.K. PHARMACOVIGILANCE

UK’S EXIT FROM EU

Brexit (British Exit) is the UK’s decision of withdrawing itself from the European Union (EU). On June 23rd, 2016, U.K. took the bold decision to leave the European Union. Following this decision, on 29 March 2017, the UK government invoked Article 50 of the Treaty on European Union for its legal withdrawal from the union by 29, March 2019. After its withdrawal from the EU union, it has chosen not to seek for a permanent membership of the European single market or being part of the EU customs union. It has also assured to cancel the European Communities act of 1971 to integrate the existing European Union Law into it.

OVERVIEW OF UK’S PHARMA SECTOR

U.K. is one of Europe’s most lucrative pharma markets with a global centre of academic pharmaceutical research and high R & D pharma spending. U.K. is also one of the key players in the European pharmaceutical industry and has the third largest biotechnology cluster. Two of the world’s biggest pharmaceutical companies AstraZeneca and GSK are headquartered in U.K. with many other large pharmaceutical companies having subsidiaries in U.K. The withdrawal of U.K. from the union will create a gap, with temporary significant interruptions and undesirable impact on public health, safety, efficacy and on the quality of medicines in the U.K.

IMPACT OF BREXIT ON U.K’S PV

The effect of Brexit would not only be on the European Medicine Agency (EMA) but also on U.K as a separate entity, which will need to establish its own regulatory system for continuous functioning of the sector. As a repercussion of Brexit, The European Medicines Agency (EMA) which is headquartered in London (U.K.) has taken the decision to relocate to Amsterdam in the Netherlands and correspondingly, EBA will relocate to Paris (France). The agencies have just over a few months’ time to prepare for the move and the subsequent start of operations in Amsterdam and Paris. However, this relocation will create a great challenge for the U.K. producers who will need a standardized regulatory process for the commercialization of drugs. The pharmaceutical companies which are using U.K. as an access point to Europe may face the challenge of relocating to a member state. Post the U.K. withdrawal from the EU, it will not have access to the European Centre for Disease Control (ECDC), European Pharmacovigilance and future medical device (EUDAMED) databases and the integrated EU vigilance processes. This may have an unfavourable impact on U.K. producing and supplying quality medicines and vaccines, as it will not have any rights to detect side effects and respond to safety issues. As a result, PV activities conducted in the U.K. may not be acknowledged by the EU and pharmaceutical companies to carry out PV studies in U.K.

Post-Brexit, the Pharmacovigilance scenarios may be different and remains unclear at present. U.K. can maintain the same alignment with that of the EU pharmacovigilance regulations system and has the right to adapt and contribute to the developments of pharmacovigilance or has the freedom to ignore them. This might put the U.K. pharmacovigilance service providers in a dangerous situation with pharmaceutical companies showing no interest to perform testing within U.K. and to commence medical studies.

PSUR single assessment procedures which were introduced as part of safety referrals and work sharing assessment to reduce the duplications of PSURs (Periodic Safety Update Reports) submitted by Marketing Authorisation Holders for activities across EU. The challenge now the industry faces is to establish the authority (previously done by MHRA) that will carry out the PSUR single assessment procedure post-Brexit.   Other EU member states should ideally be ready with resources to perform the assessment in the same way post the exit of U.K. from EU. Similarly, it might result in heavy loss of revenue for MHRA as its member state competent authorities are used to accomplish the assessment.

According to Thomas Lonngren, former executive director of the EMA, about 20% of the EMA’s resources, majority of EU QPPVs (Qualified Person Responsible for PV) (Estimated to be 153 QPPVs among 1,358) are from U.K. and after the Brexit, there are chances that EMA will lose these resources. These resources can either continue as a QPPV and can relocate to any other countries of EU or can relocate to U.K. within a marketing authorisation holder (MAH). However, despite having an enormous wealth of knowledge & experience in Pharmacovigilance, their future is blurred. U.K. might find it difficult with the licensing part of the drugs if it becomes significantly diverse or expensive in U.K.

Though the Pharmacovigilance industry will shake up a little bit, at this point of time, it is highly unclear how the U.K. will address the issues such as orphan drug designation, exclusivity and patents.

However, certain planning or measures can be taken to have no or less impact from Brexit. Transition plans and technical decisions for how the pharmaceutical companies should function in both EU and UK after the Brexit can certainly help in smooth transition. EMA has already started its planning strategy by checking the details of rare medicine and the risk of their supply shortages. It has instructed companies to come up with preparation to avoid the risks in supplying medicines. Whatever the challenges are we hope U.K. would rise to them and resolve all of them.

Some of our Industry leaders notes:

European Parliament Directive 2001/83/EC – Article 104 requires: “As part of the pharmacovigilance system, the marketing authorisation holder shall (a) have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance; the qualified person referred to in point (a) of the first subparagraph shall reside and operate in the Union and shall be responsible for the establishment and maintenance of the pharmacovigilance system. The marketing authorisation holder shall submit the name and contact details of the qualified person to the competent authority and the Agency.”

Reference:   Vicki Edwards, QPPV and head of Affiliate Vigilance Excellence at AbbVie

https://bit.ly/2BjxNQE

The UK is fully committed to continuing the close working relationship with our European partners… As Theresa May, the UK Prime Minister, has stated, we want deep, broad and dynamic co-operation and in this context, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.”

Reference:   Jeremy Hunt, Business Secretary Greg Clark and Health Secretary.

https://bit.ly/2KXjdxS

Important Dates: 

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References:

http://wsqms.com/newsletter/files/31/20160630_BrexitandPV.pdf
https://www.repository.cam.ac.uk/handle/1810/267730
https://www.pharmaceutical-journal.com/opinion/blogs/into-the-unknown-uk-pharmacovigilance-after-brexit/20202803.blog?firstPass=false
https://onlinelibrary.wiley.com/doi/abs/10.1002/psb.1601
https://www.pwc.nl/en/brexit/documents/pwc-brexit-monitor-pharma-life-sciences.pdf