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Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.
The United Kingdom government has released a paper setting out its position on issues that will affect the availability of goods after Brexit. UK politicians want many regulatory factors relevant to drugmakers to remain the same immediately after Brexit, but to achieve this goal they will need persuade European negotiators to revise their position.
The UK position paper covers how to achieve continuity in the availability of all types of goods, not just drugs and medical devices. Yet, the document refers to multiple factors of specific relevance to makers of health products, including good manufacturing practice (GMP) certification, authorized representatives and qualified persons. The UK's vision for how Brexit will, or more accurately, will not, affect these factors differs from that sketched out by the European Union so far.
The overarching difference relates to the status of products that are placed on the market after the UK leaves the EU. In its earlier position paper, the European Commission called for a withdrawal agreement that ensures products placed on the market before the UK leaves the EU can legally be sold in both territories. The document does not comment on the status of products that come to market after the UK leaves the EU.
This lack of detail has raised concerns that products made in the UK that come to market after 29 March 2019 will not have regulatory clearance for sale in the EU.
The European Medicines Agency (EMA) outlined the biopharma-specific consequences of this position in a question and answer text published earlier this year. Following the Commission's lead, the Q&A treats the UK as a third country as of 30 March 2019, meaning drugmakers will need to relocate aspects of their operations, including qualified persons and batch release sites, to mainland Europe by the day of Brexit.
In its position paper, the UK envisions a less-decisive split.
"The UK proposes that for any compliance activity recognized through the withdrawal agreement, the authority and business should be able to continue to carry out ongoing functions for relevant products or types of products for both UK and EU markets and this activity can take place in their location as at the date of withdrawal," the UK wrote in its position paper.
Citing the example of qualified persons involved in the testing and batch release of medicines, the UK argues allowing compliance activities to continue as before will "avoid unnecessary disruptive transfer of activities between the EU and the UK." The UK's point hints at its preferred long-term regulatory relationship by stating it wants to avoid the duplication of activities, "particularly where the UK's aim is for this activity to be recognized as part of a future relationship."
The UK also wants all approvals, registrations, certificates and authorizations to remain valid after Brexit, avoiding the situation in which products released on 29 and 30 March have different legal statuses. Another section of the position paper covers the UK's desire to continue working with the EU on product oversight activities such as adverse event reporting. The UK acknowledges this will require both sides to have confidence in the competence of each other's regulatory bodies.
Given the current links and regulatory equivalence between the two sides, this and other aspects of the UK's position paper are achievable. The challenge is the topics are a small slice of the many interconnected Brexit issues, some of which, such as the UK's attitude toward the European Court of Justice, could hinder progress in multiple areas.
The UK wants to start discussing these issues as soon as possible, but the EU favors sequential, not parallel, talks. This means both sides must agree the terms of the separation — including the divisive question of how much the UK owes the EU — before the future relationship is discussed. With the UK due to crash out of the EU on 30 March 2019 unless a transitional agreement is reached, there is relatively little time to resolve the issues. To simplify matters, business trade group CBI wants the UK to stay in the single market and customs union in the near term.
UK Position Paper, ABPI-BIA Statement, CBI Statement, EU Position Paper, EMA Q&A
European regulators inspected a record number of contract research organizations (CROs) last year. The Committee for Medicinal Products for Human Use (CHMP) requested eight inspections of CROs, seven more than in 2015, and other national programs assessed 70 service providers.
Both figures are at the top end of those recorded over the previous five years. From 2011 to 2015, CHMP ordered 13 CRO inspections, only five more than it requested in 2016 alone. The most CRO inspections ordered in any single year prior to 2016 was five.
National agencies also inspected CROs unusually often last year. The 70 inspections carried out by European inspectors operating independently of CHMP is just shy of the 72 conducted in 2011 but well above the numbers seen since then. From 2012 to 2015, national agencies averaged about 40 inspections of CROs a year.
The CRO inspection data were the standout trend in a report that otherwise largely mirrored those of previous years. The total number of deficiencies topped 1,000 for the first time since 2013, but the number of critical failings fell year on year. CHMP-requested inspections identified 93 critical GCP failings last year, 13 fewer than in 2015. The difference occurred despite 10 more CHMP-ordered inspections taking place last year.
Annual Report
EMA has awarded a contract to IMS to improve its access to data. The agency put out the tender to identify a high-quality source of data on drug use in primary and secondary care settings to complement its access to UK general practice records.
IMS, now rebranded as QuintilesIMS following its merger with the CRO, won the €1.4 million ($1.7 million) contract. EMA thinks gaining access to data through IMS will enable better assessments of infrequently used products and increase the extent to which the findings of its analyzes can be generalized.
"At a minimum, this data source should allow quantitative assessments of the usage of drugs in a subset of European practices/hospitals. Ideally it would allow linkage of the drug prescription data to subsequent clinical events and to existing clinical status and demographic variables for individual patients," EMA wrote.
Procurement Result
EMA has released draft guidelines on the preclinical documents companies should submit when applying for authorization of well-established and traditional herbal medicine products.
The draft guideline updates a text EMA adopted in 2006. Since then, EMA has accrued experience of applying the guidelines to national and European procedures. The agency has also published a clutch of documents with implications for the guideline, such as papers on the assessment of the genotoxicity of herbal substances.
EMA has tried to update the guideline in light of these experiences and regulatory changes. The text is open for comment until the end of November.
Draft Guideline
Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup