While a draft agreement for the UK’s withdrawal from the European Union led several key British officials to resign, one provision of it also drew praise from the UK’s drug industry. However, the group also expressed concerns about a separate, but related draft political declaration.
The 585-page draft agreement around Brexit, released last Wednesday, provides for a “transition period” that the UK and the EU agreed to earlier this year, which would last from the date of Brexit – March 29, 2019 – until Dec. 31, 2020. According The Guardian reported, that could also be extended to the end of 2022. During the transition period, the UK will continue to follow EU rules and regulations while the two parties finalize their trade relationship. The draft agreement will be up for a vote in the House of Commons in December.
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In a statement Thursday, the Association of the British Pharmaceutical Industry said it welcomed the agreement for a transition period, which would prevent a disruption in the drug supply during that time. “Agreeing to a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019,” ABPI CEO Mike Thompson said in a statement.
But a related draft political declaration on the relationship between the UK and EU, also released Wednesday, drew concern from the group.
The ABPI noted Monday that while the draft political declaration refers to “cooperation on matters of health security,” it does not clarify how it will protect patients with respect to medicines’ safety, public health disasters and infectious disease control. These include preventing fake or fraudulent drugs from entering the supply chain; sharing data between EU countries that flag potential problems with drugs; ensuring that the packets of medicines traveling between the UK and the rest of Europe – nearly 1 billion – are safe; and preventing and controlling infectious diseases. The group urged the two parties to include in the text specific reference to the importance of cooperating on drug regulations, as well as on science and innovation, and protecting people from counterfeit drugs and infectious diseases.
The document states that the respective drug regulators in the EU and UK – the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency – must provide each other with marketing authorization dossiers for products they have approved before the end of the transition period. The EMA regulates drugs for the EU and also for the non-EU European Economic Area countries of Norway, Iceland and Liechtenstein. Switzerland has an independent regulatory agency, Swissmedic. The EMA, currently headquartered in London, will move to Amsterdam.
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The agreement was nevertheless controversial and led to the resignation of Brexit Secretary Dominic Raab. In a letter to Prime Minister Theresa May, he wrote that “the regulatory regime proposed for Northern Ireland presents a very real threat to the integrity of the United Kingdom.” In addition, he objected to a “backstop” provision whereby the EU could effectively veto UK’s ability to withdraw. Steve Barclay, a junior minister in the Department for Health, was promoted to replace him. Other resignations included Suella Braverman, a junior minister for Brexit; Work and Pensions Secretary Esther McVey; and Northern Ireland junior minister Shailesh Vara.
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