European Regulatory Roundup: EMA Lays Out Strategy to 2020, Controversy in France (2 April 2015)

Regulatory NewsRegulatory News | 02 April 2015 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA, HMA Prioritize Collaboration in First Joint Strategy Document

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released their first joint strategy document. EMA and HMA teamed up on the five-year plan after accepting challenges such as antimicrobial resistance and Ebola require a more coordinated approach than was used in the past.

In the document, EMA and HMA lay out how they plan to address a wide range of topics, from incentivizing the development of products to counter antimicrobial resistance to strengthening collaborations between medicine and medical device regulators. The 16 disparate goals covered in the document are linked by an overarching theme, namely the need for more collaboration between Europe and national-level authorities to address sizable problems while avoiding duplicating efforts. 

The focus on collaboration and sharing means the document inevitably touches upon some controversial topics, such as the Transatlantic Trade and Investment Partnership (TTIP) and disclosure of clinical trial data. The big picture nature of the document means it contains few new details on either topic, but does hint at the direction in which EMA and HMA are heading. More, not less, transparency and mutual reliance is on the agenda.

Referring the clinical trial transparency policy, the authors wrote: “The network will need to consider extending this level of transparency to all of its work.” Similarly, the policy document calls for authorities to consider extending existing cooperative agreements on the assessment of generics to include innovative medicines, sharing more data on drugs across their life cycles and relying on inspection reports from other authorities. – Nick Paul Taylor

Strategy Document, Press Release,

What do Regulatory Pros Need to Know About Personalized Medicines and Companion Diagnostics in the EU?

The shift from “one size fits all” medicinal products to more targeted and customized drugs is introducing new challenges for the people involved in the development and commercialization of such products.

One of those challenges: Knowing how to bring your personalized medicine product to market. Want to learn how? Attend this upcoming RAPS workshop and hear from experts and EMA regulators involved in the regulation of personalized medicine. Register by 11 May 2015 to attend this essential event. [Read More...]

EMA’s Conditional Approval Plan Enters Second Phase

EMA has picked eight drugs to enter the second phase of its adaptive pathways initiative, which will conditionally approve products in restricted populations based on small, early clinical trials. Meetings to discuss what is next for the select group of experimental drugs are due to start on April 7.

Names of the companies or drugs involved in the second stage of the process are yet to emerge, but EMA has revealed the broad therapeutic fields covered by the first batch of candidates. An advanced therapy — the term EMA uses for treatments based on genes, cells or tissue engineering — will be discussed at the meeting on April 7. The other seven drugs to be discussed include treatments for forms of cancer and rare diseases.

Over time, the scope of the program could expand significantly. “I think this is a way of working that is applicable to many drugs,” Tomas Salmonson, chairman of EMA's Committee for Medicinal Products for Human Use (CHMP), told Reuters. The next step is to define the data each product will need to win conditional approval, a process in which EMA will involve health technology assessment groups such as Britain’s National Institute for Health and Care Excellence (NICE). – Nick Paul Taylor


UK Drug Review Committee Undergoes Triennial Review

The UK Department of Health has completed its triennial review of the Commission on Human Medicines (CHM). The UK Government requires all Non-Departmental Public Bodies (NDPBs) to be reviewed for function and cost-effectiveness.

The review of CHM concludes that the committee should continue to operate in its current form and makes several recommendations to improve the committee’s performance. In most areas, CHM was found to be mostly or fully compliant. CHM was found “not compliant” in four of the 26 provisions the review is based on. However, due to the size and nature of CHM, the areas of non-compliance were not found to be significant issues.

The recommendations include increasing communication between CHM and other relevant healthcare bodies, creating a website to advertise Expert Advisory Group (EAG) openings and increasing training initiatives for commissioners and EAG members. Finally, the review addresses the difficulty CHM commissioners face in securing time off from work for the 11 CHM meetings held each year. The review concludes that the Department of Health and Chief Medical Officer should promote CHM participation to employers upon appointment or reappointment.

The government is currently drafting the outcome of similar reviews it conducted of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE). – Michael Mezher


France’s ANSM Investigates Committee Members’ Links to Pharma

French regulator ANSM has begun an internal investigation after Mediapart alleged members of independent approval and reimbursement committees advised pharmaceutical companies secretly. ANSM initiated the investigation after consulting with the French Health Minister Marisol Touraine.

The allegations are very serious. Mediapart reports members of committees advised companies on the best ways to make their cases for approval and reimbursement. French authorities have faced similar accusations in the past, notably during the scandal regarding Servier’s weight-loss drug Mediator, which was sold in the country for 30 years despite concerns about lethal side effects. ANSM took steps to become more transparent in the wake of the controversy. 

Officials in other parts of the French administrative machinery have also faced criticism over their links to pharmaceutical companies. In April 2014, an advisor to French President François Hollande resigned after Mediapart alleged he worked as a consultant for Lundbeck while also holding a position as an inspector at the general inspectorate for health affairs, Igas. – Nick Paul Taylor

ANSM Notice (French), Mediapart (English) (French)

The Voice of Patients in Scientific Advisory Group Meetings

The European Medicines Agency (EMA) released an explanatory document on the role of patient representatives in scientific advisory groups (SAGs). EMA organizes SAGs and expert groups to address specific scientific and therapeutic topics, and ultimately advise the agency when it conducts evaluations. SAGs are typically called in when EMA’s Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance and Risk Assessment Committee (PRAC) need additional expert advice.

EMA invites patient groups to SAG meetings to provide their “perspective and experience” in order to better inform the SAG and companies involved. While the meetings are confidential, they can provide patients an opportunity to engage in the drug development and approval process. – Michael Mezher


EMA Posts Draft Q&A on Environmental Risk Assessments

EMA has posted a draft update to the Q&A document covering environmental risk assessments (ERA) for drugs. The draft guidance includes new details on when in the marketing authorization process companies should submit an ERA and more expansive explanations of the tests that are required.

Publication of the draft Q&A comes three years after EMA finalized the original document. Since then, real-world use of the document has led EMA’s Safety Working Party to conclude it needs to further clarify certain topics, such as the data companies must supply to justify the absence of a complete ERA.

EMA has made changes to more than half of the 17 questions covered in the document and is only accepting feedback on the topics it has revised. Interested parties can submit their comments until June 30. – Nick Paul Taylor

Draft Q&A

CHMP Recommends Eisai Cancer Drug After Accelerated Assessment

CHMP has recommended Eisai’s thyroid carcinoma treatment Lenvima for approval after reviewing the drug under the accelerated assessment program. Lenvima was granted a speedy decision because of the potential for it to help patients who fail to respond to treatment with radioactive iodine.

The committee made the recommendation in a batch of decisions that also included a nod for the next-generation human papillomavirus vaccine, Gardasil 9. Sanofi Pasteur MSD — the joint venture that sells Gardasil in Europe — still faces negotiations with national reimbursement bodies, though.

CHMP also recommended a drug to prevent chemotherapy-induced nausea from Helsinn Birex Pharmaceuticals and a type 2 diabetes therapy from Boehringer Ingelheim. – Nick Paul Taylor

Press Release

Controversy Over Off-Label Prescriptions in UK

The BJM has released a two-part investigative report on the controversy in the UK surrounding two drugs used to treat wet age-related macular degeneration (AMD). One of the drugs, Lucentis, is licensed to treat AMD but is considerably more expensive. The other, Avastin, is not licensed to treat AMD, but is commonly prescribed off-label to treat AMD and costs between 10 and 20 times less than Lucentis.

Before Lucentis entered the market in the UK, Avastin was widely prescribed to treat AMD. However, once Lucentis was approved, clinics were pushed to prescribe it instead of Avastin, as the UK’s General Medical Council (GMC) “discourages off-label prescribing when there is a licensed alternative.”

In the eight years since Lucentis entered the market, several governments have called on Roche, the maker of Avastin, to apply for the drug to be indicated for treating AMD. The issue is complicated by the fact that Roche co-developed Lucentis with Novartis, and markets the drug itself in other countries. – Michael Mezher

The BMJ part 1, part 2

Other News

An investigation by the European Commission (EC) has found no evidence the exemptions to price freezes Germany offers to pharma companies are a form of state aid. The ruling clears Germany to continue with its policy, which exempts companies from rebate-based price freezes if they can show the financial burden on them would be too great. Reuters

EMA’s new fee schedule came into effect on 1 April 2015. The fees have decreased by 0.1% to reflect the rate of inflation over the past year. A full explanation of the fees can be found here.

Britain is to make a meningitis B jab part of its national vaccination program after the government reached a deal with GlaxoSmithKline. Government advisors recommended the vaccine last year, but the inability to agree on a price with its then-owner Novartis delayed adoption. Now, with Glaxo having bought Novartis’ vaccine unit and cut the price of Bexsero, the deadlock has been broken. Reuters

EMA has released a concept paper on quality documentation for medicines used in clinical trials, a topic it last addressed a decade ago. The paper lays out areas in which the 2006 guidelines have been left behind by legislative and scientific changes. More precise requirements for impurities, stability and other critical aspects are among the changes planned by the EMA working group. Concept Paper

Baxter has picked up a CE Mark for its connected peritoneal dialysis (PD) system. The device allows healthcare professionals to monitor the PD treatments patients administer to themselves at home and tweak the dose when needed. Having received the CE Mark, Baxter plans to start selling the devices in parts of Europe in the next few months. Press Release

EMA has published final guidelines on the clinical investigation of treatments for lupus and a form of kidney inflammation associated with the disease. The guidelines — which are the result of a two-year drafting and consultation process — lay out each step in the clinical development of a lupus drug, from patient selection through the choice of primary and secondary endpoints. Guidelines

As of 1 April 2015, MHRA is now accepting submissions for Certificate of Free Sale (CFS) for medical devices exported outside the European Economic Area. The agency announced last month that it will be taking over the responsibility of issuing these certificates from the Department of Health.

UK Labour Party is proposing to cap the amount of profit companies that provide services to the National Health Service (NHS) can make at 5 percent. Labour Party leader Ed Miliband has clarified that the proposed cap would not apply to pharmaceutical companies, and would specifically apply to companies that provide services to the agency.

EMA’s Biologics Working Party (BWP) has released its recommendations for the 2015/2016 seasonal influenza vaccine composition. The recommendation covers composition for trivalent and quadrivalent vaccines, as well as information on labeling requirements.


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