Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Boehringer Warned Over Beer and Lederhosen at Scientific Symposium
The Prescription Medicines Code of Practice Authority (PMCPA) has ruled Boehringer Ingelheim’s allowance of the drinking of beer and wearing of lederhosen at a scientific symposium is a breach of the UK’s Code of Practice. Boehringer held the event in Germany, but the presence of two speakers from the UK brought it under the jurisdiction of PMCPA.
Speakers at the event drank beer on stage and one wore lederhosen, activities the pulmonologist who complained to PMCPA felt were “not appropriate” for a discussion of idiopathic pulmonary fibrosis, PMLiVE reports. The panel convened to review the case ruled Boehringer had failed to maintain high standards, but decided against levelling its strongest charge of bringing disrepute on the industry at the company.
Boehringer joins a short list of biopharma companies to receive alcohol-related warnings in the UK. In 2013, Roche was ruled to have breached the code after some employees drank to excess at a party following a scientific conference.
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Committee Comments Show Fundamental Disagreements Over TTIP
Proposed changes to the Transatlantic Trade and Investment Partnership (TTIP) have exposed the breadth of responses to the plan. The Committee on the Environment, Public Health and Food Safety alone has suggested 11 different versions of a short paragraph to outline the purpose of TTIP.
Collectively, the 11 responses from this narrow subsection of people with an interest in the trade deal show the divergence of opinions on what TTIP should try to achieve. The current draft text reads: “Whereas the TTIP is above all about regulation, about reducing or eliminating non-tariff barriers, and as such about the level of protection of human health and the environment.”
Members of the European committee proposed 11 changes in this sentence. Some of the proposals shift the emphasis onto the need for TTIP to cut tariffs, harmonize regulations and lower administrative burdens on businesses. Others play up the risk the trade deal could endanger human health and the environment. One person wants to delete the paragraph altogether.
In total the committee has proposed 314 amendments — some of which are contradictory — across 160 pages. The recommendations will now pass to the European Commission for consideration.
Amendment 1-156 I Amendment 157-314
EMA Moves to Weekly Type II Variation Assessments
The European Medicines Agency (EMA) has made further revisions to its advice to industry on pre- and post-authorization procedures. Changes in the new editions cover type II variations, the naming of medical products and pre-authorization good manufacturing practice (GMP) inspections.
EMA felt the changes to type II variations were significant enough to justify a press release. From March, EMA is introducing weekly start dates for type II variation assessments in an attempt to offer applicants more flexibility. In some cases, EMA will now be able to conclude the variations outside the periodic Committee for Medicinal Products for Human Use (CHMP) plenary meetings.
The move is part of a broader rethink of the timelines and processes for handling the assessment of type II variations, which are defined as changes that may have a significant impact on the quality, safety or efficacy of a product. EMA began to revise its approach in response to the structural reorganization it initiated in September 2013.
Other changes to EMA’s Q&A advice documents include tweaks to the process for proposing names for branded medical products. Applicants can now propose up to two names, half of what EMA used to allow. Once the Name Review Group has accepted the names, companies will only be able to propose more if new safety concerns or other issues that affect the branding are identified.
Pre-authorization I Post-authorization I Press Release
MHRA Advert Standards Unit Preps for Launch of Innovative OTC Products
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted oversight of innovative over-the-counter (OTC) drugs as a key task for its advertising standards unit in 2015. MHRA is paying particular attention to the imminent launches of a cigarette-like, nicotine-containing product and an emergency hormonal contraceptive.
Officials at MHRA plan to work with the Proprietary Association of Great Britain (PAGB) — an OTC trade group that vets members adverts — and the manufacturers to prevent problems before they arise. The novelty and nature of both products raises the risk of a clash between the expectations of regulators and marketing strategies of manufacturers. MHRA is keen to prevent this outcome while also working toward the establishment of a set of principles for advertising such products.
The regulator made the comments in a document to review its activities last year and look forward to its plans for 2015. MHRA received far fewer complaints about adverts in 2014 than in either of the previous two years. The figure was down 32% on 2013, in part because of a dropoff in the number of complaints about homeopathic products. People red-flagging adverts for botulinum toxin products continue to account for the bulk of comments received by MHRA.
Most of the questionable adverts are still found on websites, although MHRA once again noted increased use of Facebook, Twitter and other forms of social media to peddle products. MHRA added a section to its Blue Guide on social media adverts last year.
MHRA Report I Press Release I Regulatory Focus
Europe Becomes First Western Market to Approve Stem-Cell Therapy
The European Commission has approved Chiesi’s Holoclar, making it the first regulator in the Western world to approve a medicine containing stem cells. Holoclar is used to treat the limbal stem cell deficiency that can result from physical or chemical burns to the eye.
An EMA committee recommended approval of the stem-cell therapy in December, but the commission only signed off on the paperwork this week. The final nod clears Italian drugmaker Chiesi to begin selling Holoclar 15 years after it demonstrated proof of concept for the therapy and seven years after it received orphan drug status.
“The authorization process has been long and complex,” Professor Michele De Luca, scientific director and co-founder of Holostem, which is manufacturing Holoclar, said in a statement. The novel nature of the therapy — which is a living-tissue product that looks like a contact lens — was the cause of the drawn-out approval process.
Press Release I FierceBiotech | Regulatory Focus
The chairs of EMA scientific committees and coordination groups will no longer need to sign opinion documents from March 1. EMA is changing its signing policy to “streamline the processing of opinions documents,” such as recommendations and agreements. Chairs will continue to sign divergent positions. EMA Statement
MHRA has told British healthcare professionals about a consent decree between the US Food and Drug Administration (FDA) and Atrium Medical. The alert advises users of the devices covered by the consent decree to assess whether alternatives are available. Any organization that wants to buy new stock from Atrium must sign the Certificate of Medical Necessity and return it to Atrium’s parent company, Maquet. MHRA Statement
The Icelandic Medicines Agency (IMA) has introduced electronic signatures. Initially, IMA will use a mix of handwritten and electronic signatures, but plans to gradually increase its use of the digital format to reduce errors, paper use and postal costs. The electronic signatures have the same legal status as their handwritten counterparts. IMA Release
Vygon has begun recalling its Vyclic Colour 3-way stopcock from the UK. MHRA has told healthcare professionals not to use the product because there is a risk the paper side of the primary packaging can puncture, affecting the sterility of the stopcock. MHRA Notice