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

HTA Network Posts Paper to Encourage Cooperation on Drug Assessment

The European Commission's HTA Network has posted a reflection paper outlining how national health technology assessment (HTA) groups can cooperate and reuse each other’s work. Pharma companies are looking to the document and the broader HTA cooperation agenda to standardize processes and eliminate some of the duplicated efforts inherent in bringing a drug to market in Europe today.

The reflection paper attempts to address some of these concerns, notably by making broad and specific recommendations on ways national HTA groups can cooperate. HTA Network singles out assessment reports, evaluation-enabling tools and evidence-generation initiatives as areas in which national HTA groups can work together. A willingness to share and reuse HTA-related work is seen as vital if the existence of the European Union is to benefit the drug assessment process.

“If the reuse is not happening to the desired extent, there is the risk that the EU cooperation remains an interesting exercise but with limited value for national/regional HTA activities,” HTA Network wrote. The report recommends HTA bodies move toward joint reports by setting up processes for defining the scope of collaborations and sharing information. HTA Network also lists tools, such as the HTA Core Model and training materials, that national bodies should share.

The challenge for HTA Network is to know how far it can push the cooperation and reuse agenda. Reimbursement decisions are a fiercely defended national responsibility. While few people think the patchwork of approaches to HTAs that exists today makes for an efficient system, any attempt to harmonize processes risks angering member states, particularly at a time when Euroskeptic political parties are gaining ground in France, the United Kingdom and other parts of the Union.

HTA Network tries to downplay such concerns in the reflection paper, referring repeatedly to the fact its recommendations are subservient to the decisions of member states. The question is whether the model of permanent HTA cooperation envisioned in the reflection paper can be implemented effectively without provoking a backlash from those wary of the transfer of powers from member states to Europe.

Reflection Paper

EMA to Start Major Herbal Medicine Safety Monitoring Program

The European Medicines Agency (EMA) is to start monitoring the medical literature for adverse events related to valerian, St John's wort and other widely used herbal remedies. EMA will initially monitor 50 groups of over-the-counter and prescription drugs before adding herbal medicines as part of an eight-fold expansion of the program later this year.

A full monitoring program of 400 active substance groups is due to commence in September, but EMA is starting the first phase of the project in six weeks. The first 50 active substance groups to enter the program include common OTC products such as paracetamol and ibuprofen, as well as widely-prescribed prescription drugs, notably the ingredients in the statins Lipitor and Zocor. EMA will monitor the literature databases EMBASE and EBSCO for reports of adverse events.

The plan is to add the other 250 drugs and 100 herbal medicines to the program in September. EMA has already released the full list of the products it will keep tabs on, the herbal section of which is topped by the sleep aid valerian, depression remedy St John’s wort and eucalyptus. Many such herbal remedies are considered safe — if not necessarily effective — but there are reports of adverse events related to their use.

Research has linked St John’s wort, a common name for the hypericum plant, to photosensitivity that could damage cells and side effects that raise doubts about its use in people with certain mental disorders. Once hypericum is added to the monitoring program, EMA should be alerted whenever it is associated with an adverse event in the medical literature, theoretically leading to a more accurate representation of its safety profile.

Press Release, Regulatory Focus, More

PRAC Starts Review of Biogen’s Tysabri

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has begun a review of Tysabri, a multiple sclerosis medicine linked to higher risk of progressive multifocal leukoencephalopathy (PML). The review will assess ways to improve the advice provided to healthcare professionals and patients.

Specifically, PRAC will look at whether new understanding of the risk of PML among people who take Biogen’s Tysabri can inform the development of better advice on how to manage the danger. PML, which is caused by the infection of the brain with JC virus, is thought to occur more frequently in people who take Tysabri for more than two years or who have received an immunosuppressant prior to starting treatment with the multiple sclerosis drug.  

Such knowledge could help physicians to make more informed decisions about whether the benefits of Tysabri outweigh the risks for a particular patient. PRAC started to assess how EMA can help physicians make such decisions at a meeting late last week. The meeting also marked the start of a review into the use of inhaled corticosteroids to treat chronic obstructive pulmonary disease. PRAC is assessing the risk of pneumonia associated with the treatment.

PRAC Meeting Highlights, Medscape

EMA Adopts Environmental Policy

EMA has adopted a policy outlining its approach to environmental matters and the responsibilities of the employees charged with enacting the strategy. The six-point policy applies to all EMA’s activities, including its headquarters in London and other facilities.

The onus on EMA to protect the environment comes from the European Union, and its policy is shaped by the approach of its parent organization. In the policy, EMA commits to promoting environmental management practices across the organization, controlling its carbon emissions and complying with the law. EMA also commits to sharing best practices with other EU agencies and working with a Green Group to spread good environmental practices internally.

An environmental officer (EO) and environmental ambassadors (EnvA) are responsible for enacting these policies at EMA. The EO is tasked with the development and management of a program that fits with EMA’s environmental objectives, as well as the maintenance and review of relevant documents. Some of this work will involve liaising with a Green Group, a team set up by the EnvAs to act as a bridge between the EO and EMA staff.

EMA Environmental Policy 

Other News:

French regulator ANSM has placed further restrictions on the prescription of acne medicine isotretinoin. Dermatologists are now the only healthcare professionals with the power to make an initial prescription for isotretinoin. ANSM barred general practitioners from prescribing the drug after concluding they were failing to comply with its pregnancy prevention program. ANSM Notice

EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the approval of a clutch of new drugs. CVMP issued positive opinions on vaccines for chickens and dogs, as well as a systemic arterial hypertension treatment for cats. The committee also ruled on five applications for the animal medicine equivalent of orphan status. CVMP Meeting Notes

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has shared a safety alert covering certain ResMed ventilators. ResMed identified the need for an alert after a preliminary analysis of a trial identified an increased risk of cardiovascular death in some groups of patients. MHRA is investigating the issue. MHRA Notice

EMA has released draft guidelines on the clinical development of fixed-dose combinations (FDC). The draft explains how companies can justify the need for an FDC and the safety and efficacy data EMA will want to see. Regulatory Focus