Posted 07 December 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Stands Firm on Demand for UK to Pay for EMA’s London Exit
The European Commission has reiterated its demand for the UK to cover the cost of the European Medicines Agency’s (EMA) withdrawal from London. That would mean the UK paying the €400 million ($470 million)-plus bill EMA will face as result of breaching its rental agreement.
European officials first stated their belief the UK is liable for the cost of EMA leaving London in the months after the vote to leave the European Union. Since then, the UK government has grumbled about the prospect of settling its broader debts — one prominent politician said the EU can “go whistle” — but in recent weeks news articles have suggested both sides are converging on a final payment of around €50 billion.
Neither the UK nor EU has publicly put a price on the separation or broken down what obligations will be covered by the settlement. However, the Commission has been clear that the UK is on the hook for the cost of getting EMA out of London.
“The United Kingdom should fully cover the specific costs related to the withdrawal process, such as the relocation of the agencies based in the United Kingdom,” the Commission wrote this week.
That statement, which echoes one made in May, was released as part of a document covering the relocation of EMA to Amsterdam, the Netherlands. The Commission published the document in conjunction with a regulation formalizing the selection of Amsterdam as EMA’s new home.
While the Commission wants the UK to pay for the costly withdrawal — the rent component alone neared €450 million at the last count — it recognizes the financial settlement may not be reached until after EMA needs the money. As such, officials anticipate dipping into the EU budget.
“The Commission will assess possible additional funding needs to be channelled through the EU budget in cooperation with [EMA]. As necessary, the Commission will present relevant proposals to the European Parliament and the Council in the context of the annual budgetary procedure for 2019, and if necessary for 2018,” the Commission wrote.
Some processes need to start soon. With EMA fretting over the brief window it has to make the move, the Commission wants to begin the process of arranging for the cost of designing the new offices as soon as possible. The goal is to start the process by early next year at the latest.
PRAC Starts Probe Into Allergan, Bayer Drugs After Adverse Events
The Pharmacovigilance Risk Assessment Committee (PRAC) has initiated separate reviews into the safety of Allergan’s Esyma and Bayer’s Xofigo. PRAC’s interest in the drugs stems from reports of adverse events linked to their use.
Esyma, a treatment for uterine fibroids, is in PRAC’s sights after four reports of serious liver injury. Three of the cases ended in liver transplantation. PRAC’s initial assessment suggests Esyma may be the cause of the adverse events, prompting the EMA committee to start a full review. However, it has opted against issuing a warning at this time.
The next step is for Allergan to respond to PRAC’s questions. PRAC wants Allergan to provide it with safety data to help evaluate the risk of liver failure and information on the potential ways in which Esyma may result in such adverse events. Allergan has until 12 January to answer PRAC’s questions.
PRAC adopted a tougher opening position against Bayer’s Xofigo. The committee’s first move was to warn about the use of the prostate cancer drug in combination with Johnson & Johnson’s Zytiga. PRAC took up that position after reviewing data from a clinical trial combining the drugs, in which the death rate was seven percentage points higher — 27% versus 20% — in the Xofigo arm than the placebo cohort. Fractures were also more common in the Xofigo arm.
Bayer must now submit its analysis of the full dataset and provide reasons for any differences in the outcomes between the two arms. PRAC has also asked for a “comprehensive discussion” of why the Zytiga combination trial that triggered the warning has generated different results than other studies and early access programs.
PRAC initiated the reviews at a meeting at which it concluded its reevaluation of an earlier ruling on modified-release paracetamol. The EMA committee stuck with its original recommendation to suspend such products from the market.
UK Admits it Has Not Systematically Assessed Industry-Specific Effects of Brexit
The politician in charge of Brexit has admitted the UK is yet to systematically assess the impact of leaving the EU on the pharmaceutical industry or any other sector.
Earlier this year, Davis said the government had already done nearly 60 “sectoral analyses” and that its reports went into “excruciating detail.” Those claims came in for scrutiny after pParliament made the government share its research, leading to Davis being hauled before a meeting of the Exiting the European Union Committee to answer questions.
Under questioning, Davis detailed what the government has and has not done to assess the effects of Brexit.
“There’s no systematic impact assessments,” Davis said.
Davis’ interrogator, Labour politician Hillary Benn, then sought to clarify whether the government had performed impact assessments on the automotive, aerospace or financial service sectors.
Davis responded “no” to the questions about those three sectors, before shutting down the line of inquiry by saying “I think the answer is going to be no for all of them.”
The implication is that the government is yet to thoroughly assess how the different regulatory systems under which UK drug companies could be operating in 16 months will affect the industry.
Meeting Replay, Financial Times
Commission Seeks Patient Organization Representatives for Orphan Drug Panel
The Commission has put out a call for three representatives of patient organizations to join EMA’s Committee for Orphan Medicines (COMP). The patient representatives will attend COMP meetings alongside people nominated by each member state and another three put forward by EMA.
Officials are looking for candidates to replace members whose three-year terms are due to end on 30 June. Current members may reapply, but the Commission’s Directorate-General for Health and Food Safety is also casting its net wider. Interested parties have until 20 December to apply for the positions.
The people who are chosen will start in the role on 1 July and serve until 2020. Over that period, the patient representatives will attend monthly COMP meetings, at which they will be expected to ensure the committee considers the needs of patients in its deliberations.
EMA’s Good Manufacturing and Distribution Practice Inspectors Working Group has released its 2016 report. The report, which is dated August but was put online this week, shows EMA issued 19 GMP non-compliance statements last year. India, with 12, received the most non-compliance statements. In 2015, India received six of the 13 non-compliance statements issued by EMA. Report
The Committee for Medicinal Products for Human Use (CHMP) has adopted a revised version of a guideline on evaluating anticancer drugs in humans. The 43-page document covers the full spectrum of oncology clinical development, from Phase I through pivotal trials and safety studies. CHMP’s adoption of the text positions it to come into effect on 1 April. Final Guideline