Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Council Makes Medical Device Reform Breakthrough After Years of Deadlock
The Council of the European Union has published a compromise text on medical device regulation, three years after the Commission first proposed reworking the legislation. Making the breakthrough has set the stage for a discussion of the draft at the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting this week.
Officials at the European Commission proposed changing the medical device regulations in 2012 to standardize approaches across the region, only to see the initiative to get stuck at the Council. After four presidencies tried and failed to advance the process, Latvia has reached a compromise in the form of a 676-page document. Health ministers will discuss the draft this week, after which it may advance to a trilogue in which the Council, Commission and Parliament will try to agree upon a final text.
The preliminary nature of the draft and range of interpretations that can be applied to some sections mean many questions remain unanswered. Lawyer Erik Vollebregt has a detailed analysis of what he sees as the standout points in the text on his MedicalDevicesLegal blog. Both Vollebregt and Politico pick out the draft's stance on the reprocessing of medical devices as a hot topic. The draft allows for reprocessing to take place when permitted by national laws, a stipulation that represents a backing away from the commission's initial ambition to harmonize standards across Europe.
Vollebregt also flags up an anticipated impact of the draft on authorized representatives, the people who carry out certain tasks for manufacturers based outside the European Union. The text makes authorized representatives "legally liable for defective devices," a vague term with big implications. "It looks like the [authorized representatives] will get a truly raw deal under this new regulation and will need to seriously consider their insurance cover and terms with the new and quite unclear liability coming their way," Vollebregt wrote.
Ireland Mulls Complaint to Commission over Pricing of Soliris
Health officials in Ireland are considering complaining to the European Commission about the price of Alexion's Soliris. Payers around the world have balked at the price of Soliris — which costs Ireland €430,000 ($484,000) a year per patient — but have ultimately caved in and reimbursed the drug.
Ireland's Health Service Executive (HSE) is one such decision maker, having agreed to pay for Soliris in February despite regarding its price tag as "exorbitant" and "astronomical." At the time, officials said they would continue to push for a drop in the price of the treatment for atypical hemolytic uremic syndrome and it now appears this campaign could lead to legal action and the filing of a complaint with the commission.
Politico reports Ireland is "considering … legal options as it seeks a better deal on the drug Soliris, [including] lodging a complaint with the EU Commission." Such a move would mark an escalation of efforts to bring down the cost of Soliris. In Belgium, a standoff over the price led to allegations Alexion was blackmailing the government, while the United Kingdom's National Institute for Health and Care Excellence questioned why Soliris costs 30 times more than other monoclonal antibodies.
EMA Follows FDA in Reviewing Safety of Type 2 Diabetes Drugs
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has initiated a review of a class of recently approved Type 2 diabetes drugs. The review began days before the U.S. Food and Drug Administration (FDA) issued its opinion on the drugs, in which it linked them to the production of dangerously high levels of blood acids.
Both reviews are focused on Johnson & Johnson's Invokana, AstraZeneca and Bristol-Myers Squibb's Forxiga and Boehringer Ingelheim and Eli Lilly's Jardiance, each of which is an SGLT2 inhibitor. The class of drugs has picked up approvals on both sides of the Atlantic over the past few years but their real-world use has led to reports of ketoacidosis, a condition in which the levels of ketones in the blood rise to an extent that the patient may be hospitalized.
EMA found reports of such adverse events in its EudraVigilance database. Some of the reports relate to the off-label use of SGLT2 inhibitor in patients with Type 1 diabetes, a population that is at risk of ketoacidosis anyway. However, even when this group is excluded, the database contains numerous cases of ketoacidosis. Invokana--which has captured a sizeable chunk of the SGLT2 market--was linked to the most adverse events, with EMA finding 63 reports of the side effect in Type 2 diabetics.
PRAC Notice, Commission Notification, FDA Alert
MHRA Reminds Industry ahead of Deadline for Online Pharmacy Logo
The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has posted a reminder about the upcoming deadline for adoption of a logo for selling drugs online. People found selling medicines online after the July 1 deadline face a fine and up to two years in prison.
Pharmacies must also register with MHRA to comply with the requirements, which were brought in at a European level as part of the Falsified Medicines Directive. When visiting the website of a registered online pharmacy, consumers can click on the logo to be taken to the organization's entry on MHRA's list of authorized retailers. Member states are responsible for enforcing the requirement.
MHRA has stepped up its activities ahead of the deadline by posting a reminder of the incoming requirements and why European politicians felt they are necessary. "Buying from an unregistered site could mean you do not know what medicines you are getting, and you could even be damaging your health," Lynda Scammell, senior policy advisor at MHRA, said in a statement.
MHRA Notice, SecuringIndustry
EMA has published a reflection paper on the assessment of cardiovascular risk for drugs to treat the heart or metabolic diseases. The draft paper outlines precautions companies can take when testing drugs against cardiovascular and metabolic diseases to ensure they do not trigger some of the side effects associated with other products targeting the same indications. Reflection Paper
The European Commission has approved Gardasil 9, the successor to the blockbuster human papilloma virus (HPV) vaccine sold in the region by a Merck-Sanofi joint venture. Gardasil 9 offers protection against five strains of HPV not covered by the original quadrivalent vaccine, an increase its developers think makes it effective against viruses that cause 90% of cervical cancer cases. Release
EMA has decided to incorporate planned guidance on electronic trial master files (eTMFs) into a broader document to be published in response to the Clinical Trial Regulation. The eTMF reflection paper was drafted as a standalone document in 2012 and underwent a public consultation. However, EMA will now include it in another guidance document. Reflection Paper
A review of phthalate-containing medicines sold in the United Kingdom has identified six products with levels of the excipient above the permitted daily exposure (PDE) now recommended by EMA. More than 50 medicines contain at least one of the phthalates covered by the recommendation but in quantities that mean they are unaffected by the PDE. BMC Pharmacology & Toxicology
The European Commission has ruled the risk assessment methods currently used for genetically modified organisms (GMOs) can be applied to synthetic biology (SynBio). Final Opinion