No Successor Yet Named For Head of UK Medicines Agency

As the deadline date for the UK withdrawal from the EU rapidly approaches, no successor has yet been named to take the place of the head of the UK Medicines and Healthcare Regulatory Agency (MHRA).

Late last fall, Dr. Ian Hudson announced that he will resign his position as CEO of the MHRA. Dr. Hudson has served as CEO of the watchdog agency since 2013 with much of his current role including serving as the UK delegate to the Committee on Human Medicinal Products (CHMP) at the European Medicines Agency (EMA). Indeed, Dr. Hudson has been the Vice-Chairman of CHMP since October 2012.

Dr. Hudson does not appear to be leaving for a particular employment alternative, rather, he stated, “I feel the time is right for a new person to guide the agency and our work through its next phase, following the UK’s departure from the European Union next year.” The resignation will take effect in September 2019, about six months after the UK leaves the EU.

With only two months to go before the March 29, 2019 Brexit date, there remains no deal in sight. According to its long-term Brexit plan, MHRA is moving forward with preparing for the possibility of a hard Brexit.

MHRA Post-Brexit

If the UK exits the EU without a deal which includes provisions for a relationship with the European Medicines Agency, the MHRA will lose access to all EU regulatory networks and will serve as a standalone drug regulator – handling all responsibilities that are currently overseen by the EMA, such as drug approvals, general oversight of medicines, and clinical trials. The MHRA has released some proposed arrangements for regulation in the case of a no-deal scenario.

The resignation of Dr. Hudson and the search for a successor to guide the agency adds a yet another layer of uncertainty as to the future of the MHRA in the aftermath of Brexit.

As the March 2019 UK withdrawal date approaches, we at Contracts Associates will continue to provide updates on our blog in relation to the impact of Brexit on existing appointments of UK entities as EU legal representatives as well as recommended revisions to UK informed consents, once the UK is no longer subject to the EU GDPR.

Thanks to Brexit – EMA Leaves London for Amsterdam

In anticipation of its move from London, the European Medicines Agency (EMA) has been working closely with Dutch authorities to help smooth its relocation to the Netherlands. The move is expected to occur by March 30, 2019.

EMA, which facilitates the development and access to medicines in the EU, has been located in London since it was established in 1995. Despite voting to withdraw from the EU in 2016, the UK had expressed hope that EMA would remain in its longtime location on Canary Wharf. But on November 20, 2017, EU Member States voted that in the wake of Brexit, EMA would not remain in Britain but would be relocated to an EU member country. Amsterdam won the competition to house the EMA and the agency has since signed a Seat Agreement with the Dutch government which will permit the EMA to function independently in its new location.

In order to best prepare for the consequences of Brexit, the move to Amsterdam, and subsequent loss of staff, the agency has initiated a temporary suspension or scaling back of various activities so that its core activities of evaluation and supervising medicines can proceed with as little disruption as possible.

Among other activities, guideline development and revision has been scaled back in order to prioritize the guidelines which address urgent public/animal health needs or are necessary to prepare for Brexit. More detailed information can be found in EMA’s Brexit Preparedness Business Continuity Plan. More reductions are expected in advance of the actual re-location to Amsterdam.

EMA has also released information for pharmaceutical companies concerning cut-off dates for appointments of (co)-rapporteurs from the UK.

Additionally, EMA has created a Tracking Tool which displays various logistics and milestones related to its relocation from London.

We at Contracts Associates are also monitoring the impact that Brexit will have on the treatment of EU citizens’ transfers of personal data to sponsor data server’s located in the UK, which will be outside of the EEA, post-Brexit. We’ll cover this in future blogposts.

 

U.S. Clinical Trial Sponsors Are Unprepared for New EU GDPR Regulation

As of May 25, 2018, U.S. sponsors of clinical studies conducted in the European Union must be in compliance with the EU’s new General Data Protection Regulation (“GDPR”) or risk the possibility of significant fines.

U.S. sponsor companies must contend with this new EU regulation and the learning curve will likely be steep—especially as the GDPR requirements contrast sharply with the U.S.’s lack of any meaningful privacy regulation.

Companies found to be in non-compliance with the GDPR risk significant fines – possibly up to 4% of total worldwide annual turnover of the preceding financial year or 20 000 000 EUR, whichever is larger. The GDPR applies to the processing of personal data which includes subjects’ names, addresses, medical information, and more—regardless of whether the processing takes place in the EU or not.

We expect that our clients will be particularly impacted by the provisions related to the stringent, new contractual Informed Consent requirements for terms concerning use of bio specimens.

The GDPR also mandates the appointment of a senior-level Data Protection Officer with expertise in data protection law. This DPO will report directly to a C-suite executive. The law also requires companies to comply with certain processes for data protection and data management.

Contracts Associates is prepared to help your company successfully navigate this new regulatory framework. Our team of attorneys can help minimize the risk of penalties by updating your contracts to ensure that all informed consent language is GDPR-compliant with regard to sample and data usage. We will help your company uphold its legal duties and obligations to EU sites and vendors by drafting new contract template terms as needed. We encourage you to start your GDPR-compliance planning by contacting our office at 781-598-8000 or emailing our CEO, Colleen Sproul, at cms@contractsassociates.com