European Regulatory Round-Up: New Face At EMA, New Rules In France and Germany

European Union

New EMA Director Takes Helm In November

Guido Rasi, now head of the Italian Medicines Agency is expected to take his post as European Medicines Agency executive director on Nov. 16.

Key agenda items for Rasi include revised pharmacovigilance legislation and a new committee on pharmacovigilance at the EMA, which will become operational in 2012.

The EMA Management Board confirmed the selection of Rasi at its Oct. 6 meeting; his appointment had been held up by an initial mistake made by the European Commission’s translation services when advertising the post in 2010 (“A Leaderless European Medicines Agency: Does It Matter?” “The In Vivo Blog,” Nov. 11, 2010).

Rasi, known in Italy for his “clean hands” approach to regulation, was nominated by the board on June 8; appeared at a hearing of the European Parliament’s Committee on Environment, Public Health and Food Safety July 13; and was endorsed by the Conference of Presidents of the European Parliament on Sept. 7. His reputation may be particularly advantageous, as Rasi is joining an agency battered by Mediator scandal, criticized for lax management, and facing calls to adopt more transparency in its operations .

EU Court Deals Blow to Stem Cell Research

Companies hoping to benefit from embryonic stem cell research in Europe have been dealt a severe blow by the Court of Justice for the European Union. In a case pitting researcher Oliver Brüstle from the University of Bonn against the environmental group Greenpeace, the court ruled that if a human embryo were to be destroyed during the creation of an invention, then the resulting product or process could not be patented. The ruling was issued by CJEU's highest court and thus cannot be appealed.

Some critics have said that the court’s ruling will spell disaster for companies in the stem cell field and put research for treatments of specific disease areas, such as Parkinson’s, Alzheimers and spinal cord injuries, in danger. But research involving adult stem cells is unaffected by the ruling.

Member States

German Stakeholders Agree On New Reimbursement Framework

After nine months of negotiations, Germany’s pharmaceutical associations and health insurers have finally come to an agreement on the parameters for reimbursement for drugs with new active ingredients within the framework of the Law on the Restructuring of the Pharmaceutical Sector (AMNOG) (Also see "New German Reimbursement Process Splits Opinion Ahead Of First Assessments" - Pink Sheet, 25 Jul, 2011.). Under the law, the reimbursement level will be set based on the added value of the drug over existing therapies. The agreement includes compromises on how to select comparators to new medicines and on how to take into account annual therapy costs of a drug when determining the level of reimbursement.

However, the stakeholders failed to agree on whether or how to include prices in other European countries as a comparator for the prices in Germany – this issue will now go to arbitration. The first reimbursement negotiations for individual products are expected to start in January 2012, following an added value assessment by the Institute for Quality and Efficiency in Health Care on behalf of the Joint Federal Committee.

Swedes Tussle Over Pharma Info To Journalists

A battle royale is about to commence in Sweden regarding whether providing information to journalists about prescription medicines constitutes advertising to the public. In May, Boehringer Ingelheim GmbH published a press release announcing that it had sought a lower price for its direct thrombin inhibitor Pradaxa (dabigatran).

At the end of September, Läkemedelsverket, the Swedish medicines agency, slammed the release as back-door advertising of a prescription medicine and intended to fine the company €750,000 unless it informed the agency in writing within 10 days that it would cease this type of “marketing” to the general public.

The Swedish industry association LIF has accused the agency of attempting to restrict freedom of speech and journalists’ access to materials. “This interpretation [of Läkemedelsverket] is in stark contrast to the long-established practice in Sweden, whereby press releases directed solely at journalists are not regarded as marketing,” said LIF Director General Anders Blanck.

NICE Deals Surprise Blow To Yervoy

In what is seen as something of a stunner to the pharmaceutical industry in the U.K., the National Institute for Clinical Excellence on Oct. 12 recommended against the use of Bristol-Myers Squibb Co.’s Yervoy (ipilimumab) for advanced malignant melanoma in people who have received prior chemotherapy. NICE’s refusal to recommend Yervoy has puzzled analysts, who have predicted sales of some $1.4 billion by 2017 in the U.S. alone (Also see "Bristol Will Leap 'Over Its Patent Cliff,' In 2013, Sigal Tells Investors" - Pink Sheet, 13 Sep, 2011.). What’s more, Yervoy already has been provided to 2,444 patients in 386 clinical centers in Europe through BMS’ Expanded Access/Compassionate Use Program.

But with treatment costs set at some £80,000 ($126,000) per course, the incremental cost-effectiveness ratio for ipilimumab was calculated at between £54,000 and £70,000 per quality-adjusted life-year gained, well above NICE’s traditional threshold of approximately £30,000. NICE also complained that the data submitted by the manufacturer primarily came from the MDX010 20 trial, in which ipilimumab was not compared with drugs currently used to treat people with advanced or metastatic melanoma.

While the institute acknowledged that the drug could potentially be very effective for a small percentage of patients, it said that the follow up from the trial was too short to determine how long this effect would last.

French Pharma Sector Reform One Step Closer

The restructuring of the French pharmaceutical sector has passed another hurdle, following the Oct. 4 Assemblé Nationale’s (Lower House’s) vote in favor of reform. The Pharmaceutical Sector Reform Act revolutionizes the work of the national medicines agency, giving it increased responsibility for pharmacovigilance and renaming it the National Agency for the Safety of Medicines and Health Care Products (Also see "Mediator Scandal Provokes Flurry of French Health Reforms But Impact Is Hard To Gauge Until The Dust Settles" - Pink Sheet, 1 Aug, 2011.).

The legislative act, which was proposed as a result of the Mediator affair, also ensures the agency’s budget is paid through health insurance and not through fees raised from the pharmaceutical industry. The agency is required to be totally transparent in its decisions and decision-making processes and will have access to all clinical trial data from companies seeking a marketing authorization.

The bill also bans one-to-one hospital visits by pharmaceutical company representatives and, to avoid conflicts of interest, requires all health care personnel to publish any dealings they may have with pharmaceutical companies. It also offers protected status to whistleblowers who flag up potential problems with drugs.

Servier’s Day Just Keeps Getting Worse

The Assemblé Nationale has piled on the misery for pharmaceutical manufacturer Servier by banning its lobbyists from entering the parliament this month, targeting particularly its representative Corinne Moizan. The move follows allegations that the company covered up cardiac risks linked to its diabetes drug Mediator (benfluorex), which is suspected of causing the deaths of up to 500 people . Servier has fought back in a printed statement, calling the Assemblé Nationale’s decision utterly derogatory and arbitrary as Moizan had not broken the parliament’s code of ethics. It added that, unlike many other companies, Servier had entered its name on the parliamentary list of lobbyists in the spirit of transparency.

Meanwhile, appearing before judges in Paris on Sept. 21, Jacques Servier, the owner of the company, reiterated that Servier had not presented false information to the French regulatory authorities. He also confirmed that the company would live up to its financial responsibilities in terms of compensating victims.

By Faraz Kermani