Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
France to Expand Scope of Sunshine Act
France has initiated a major change to its pharmaceutical industry Sunshine Act, a law which provides transparency to certain promotional and contractual activities. The plan is to expand the scope of the reporting requirements to include fees paid to healthcare professionals for services, life science consultancy Polaris reports.
Such contracts were excluded from reporting requirements when the Ministry of Social Affairs and Health set up the database of deals between the medical products industry and physicians. The French Supreme Court has now ruled the Ministry overstepped its regulatory authority by making that decision and has begun the process of overturning the policy. Significant questions remain, though.
At this stage it is unclear when the policy will come into force. France has a history of retroactively applying new laws, so it is feasible companies will need to provide evidence of service contracts dating back to the start of this year or earlier still. Details of how the fees are reported need clarifying, too. Services could be included with other benefits received by physicians or the reporting of contracts.
The changes bring France more in line with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code, which already mandates the reporting of fees for services. Companies will continue to have to report any non-service payments exceeding €10 ($11) that they make to healthcare professionals.
Politicians Kibosh Controversial Saatchi Bill
The progress of a law to give doctors in the United Kingdom legal protection when they prescribe unapproved treatments to dying patients has come to a halt. Lord Saatchi, the peer and advertising mogul behind the bill, had evolved the law to make it more palatable to the medical community, but ultimately found his plans blocked by the Liberal Democrats.
Leaders within the Liberal Democrats - which is the smaller party in the United Kingdom's coalition government - decided the bill raised too many risks of unintended consequences. Saatchi drafted the law to provide doctors who use unapproved medicines with legal protection, the lack of which he perceived to be an obstacle to the prescription of novel drugs. Critics labeled the bill a "quack's charter."
Saatchi has tweaked the bill to lessen such concerns, but many people still questioned whether it was necessary and feared it would protect doctors who made irresponsible decisions. The Liberal Democrats have decided such concerns are still valid and as such have vetoed the bill, which passed through the U.K.'s other legislative chamber unopposed.
NICE Backs Gilead's Harvoni at a Knockdown Price
The United Kingdom's National Institute for Health and Care Excellence (NICE) has once again seen value in Gilead's line of expensive, controversial but effective hepatitis C treatments. NICE followed up its recommendation for Sovaldi with a positive opinion on Harvoni.
Payers around the world have balked at the cost of the drugs, but NICE sees value at the knockdown price Gilead is charging in the UK. NICE expects a 12-week course of Harvoni - which combines the active ingredient in Sovalidi with another drug - to cost £38,979.99 ($59,830), around one third less than the sticker price in the United States.
When fed into the cost-effectiveness calculations presented by Gilead and those commissioned by NICE's Evidence Review Group, the price resulted in Harvoni having a quality-adjusted life year figure below £30,000 for multiple different groups of patients and scenarios. NICE made a similar judgment on Sovaldi, but its introduction has been delayed.
The delay is reportedly because while NICE views the drug as cost effective that doesn't mean it is affordable to the UK's cash-strapped National Health Service. Harvoni is priced slightly higher than Sovaldi in the UK.
Reuters I NICE Consultation
EMA Posts Draft Guidelines on Antimicrobial Resistance
The European Medicines Agency (EMA) has released a pair of draft guidance documents covering the use of antimicrobial veterinary products. Both documents are intended to address the emergence of antimicrobial resistance as a public health problem.
The more advanced of the two documents covers how to show the efficacy of antimicrobial animal medicines. EMA originally released the document for consultation in May 2013 and has spent the past 15 months reworking it in response to feedback. The latest version clarifies that alternative study designs to the ones listed in the guidelines may be used if justified by the applicant.
EMA's other guidance document relates to the use of antimicrobial products in food-producing animals. Treating such animals with antimicrobials can expose humans to resistant strains, a situation EMA is keen to minimize. The guidelines outline the data and methods EMA will need to see if it is to rule the benefits of using an antimicrobial animal product outweigh the risks to public health.
The comment period on the efficacy guidelines closes at the end of May, while people can submit feedback on the food-producing animal proposal until the end of August.
Efficacy Guidelines I Resistance Guidelines
NICE has called for patients to have a greater say in which medications they take. The guidelines say healthcare professionals should incorporate each patient's needs, preferences and values into their treatment recommendations. NICE hopes the guidelines will lead to "person-centered systems" that make the best use of available treatments. PMLiVE
French regulator ANSM has begun a consultation on proposed updates to good manufacturing practices (GMPs). The public consultation relates to four chapters on GMPs that collectively cover equipment, production practices, quality control and recalls. ANSM is accepting feedback on the chapters until April 2. ANSM Statement
EMA released a clutch of documents covering the use of veterinary drugs in food-producing animals. The documents cover residue depletion studies, the analytical methods used in such tests and the range of substances that fall outside the scope of regulation on animal drug remnants. Residue Depletion I Analytical Methods I Exempt Substances
European authorities have awarded CE Marks to Alere and Roche. Alere received its CE Mark for its rapid test to distinguish between HIV strains, which is designed to deliver a result within one hour. The Roche CE Mark covers its Cobas HBV assay. The assay runs on the Cobas 6800/8800 systems and allows operators to look for HBV genotypes A through H in real time. Alere I Roche
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has posted a warning about Inmed's corrugated flex tubes. Inmed issued a field safety notice (FSN) in December about the risk of the tubes cracking, but MHRA is unsure if the message has reached all users. The effectiveness of FSNs in communicating to users is an ongoing concern for MHRA. MHRA Notice
EMA's Coordination Group for Mutual Recognition (CMDh) has endorsed the Pharmacovigilance Risk Assessment Committee's (PRAC) recommendation to update the safety information for products containing ambroxol and bromhexine. An investigation by PRAC concluded the ingredients carry a small risk of severe allergic reactions. Press Release
The International Conference on Harmonisation (ICH) has released its draft implementation guide for electronic common technical document version 4.0. EMA shared the document for consultation, which will end on May 22. EMA Notice
EMA has reminded marketing-authorization holders that their fees will change on April 1. The change is tied to inflation, which EMA expects will result in companies paying 0.1% less once the new rates come into force. EMA Statement
Professor Barrington Furr , a non-executive director at MHRA, has died. Furr joined the board in 2008 after a career in industry in which he rose to the position of chief scientist at AstraZeneca. MHRA Notice