Regulatory Focus™ > News Articles > European Regulatory Roundup: Drug Pricing, Labeling and New Guidelines (11 June 2015)

European Regulatory Roundup: Drug Pricing, Labeling and New Guidelines (11 June 2015)

Posted 11 June 2015 | By Nick Paul Taylor 

European Regulatory Roundup: Drug Pricing, Labeling and New Guidelines (11 June 2015)

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

Dutch Push to Make Drug Pricing, Access Long-Term Priorities for EU Council

Dutch officials are working with politicians in Luxembourg, Malta and Slovakia to make the pricing and availability of medicines a long-term priority for the Council of the European Union, Politico reports. Collectively, the four countries will hold the presidency of the council from July 2015 to June 2017, giving them an opportunity to dictate its agenda over the next two years.

The Netherlands has already shown a willingness to try new approaches to controlling the cost of drugs, notably by partnering with its neighbor Belgium to negotiate prices for orphan medicines. Bulgaria and Romania have since adopted a similar arrangement to increase their buying power. The alliances mark a small break with the thinking that drug prices must be a national issue free from interference by other member states. The Dutch are interested in chipping away at this thinking.

Officials in the Netherlands are reportedly interested in gauging the willingness of other countries to rethink EU regulations on the pricing and availability of medicines against cancer, rare diseases and pediatric indications. Such a transfer of powers from national governments to the EU would go against the rise in Euroskepticism in several countries, but the Dutch could make progress if other member states think the model proposed can curb the cost of cancer and rare disease medicines.

A survey of patient groups in the United Kingdom shows how contentious the pricing of such drugs has become. Pharmalot reports 14% of patient groups in the U.K. rated industry drug pricing policies as good or excellent. A similarly low proportion thinks the industry acts with integrity or weighs the needs of patients into decisions. Such strong views are informed by the growing history of drugs failing to win reimbursement in the U.K. because they are thought to provide poor value for money.

As with pricing negotiations, there is a tentative but growing movement toward collaboration on the analyses that underpin these decisions. A study by the EU committee on Environment, Public Health and Food Safety released this week made recommendations to this effect, notably by calling for the creation of a European committee that performs relative efficacy assessments prior to the phase of national reimbursement decisions. Such a model would eliminate duplicated efforts.

Politico, Pharmalot, ENVI Report

EMA Ends Long Wait for Progress on Rheumatoid Arthritis Trial Guidelines

The European Medicines Agency (EMA) has published another set of draft guidelines on the clinical development of treatments for rheumatoid arthritis, continuing a regulatory update that began back in 2011. It is now almost exactly three years since the comment period for EMA’s last stab at draft guidelines closed, since when progress has stalled.

Officials at the Rheumatology-Immunology Working Party (RIWP) got the process moving again this week with the release of a heavily revised set of draft guidelines. In the 16-page document, EMA lays out what it expects of firms developing drugs in the fiercely fought, blockbuster-scale indication. The guidelines include whole sections that were not in the previous version, such as a discussion of the criteria for enrollment that calls for trials to recruit either people with early or advanced disease.

Such stratification of patient population has been made possible by advances in the early detection of rheumatoid arthritis. Other aspects of the document are also influenced by recent improvements in the treatment and testing of rheumatoid arthritis, some of which have led to EMA calling for trial sponsors to make remission their primary endpoint. EULAR-ACR remission or EULAR remission/low disease activity scores are now the way to assess outcomes, something that was not the case before.

Other notable changes between the 2011 draft and the version released this week include the addition of a section on risk-management plans and a condensation of the recommendations on trial strategy and design. EMA has given people until 29 November to comment on the draft.

Draft Guidelines

Product Labeling Requirements Streamlined in EMA Rethink

EMA has revised its approach to the information that must be included in package leaflets and the summary of product characteristics (SmPC). The changes free drugmakers from a couple of current requirements, notably the need to produce a separate SmPC for each dose of a pharmaceutical.

Now, manufacturers can write one SmPC that applies to every strength of a product, providing the current documents are identical apart from a few dose-specific details. In these cases, EMA is encouraging the use of combined SmPCs and will require no justification for the change. Some drugs will fall outside these criteria for combined SmPCs, and in these cases EMA will require documents for each strength, although a single file is acceptable for the evaluation process.

EMA has also moved to simplify the requirements for contact details. Instead of having to list contact details for company representatives in each European Union country in the package leaflet, manufacturers can now just provide the address of the appropriate person for the market in which the product is sold. Patient will still be able to access the full, EU-wide list in the product information annexes.

Press Release, SmPC Guidance

EMA Finalizes Heart Failure Trial Guidance, Posts Draft Pediatric Addendum

EMA has finalized its guidelines on clinical trials of treatments for acute heart failure and posted a draft addendum to the document outlining the process for studies in children. EMA released the documents to update guidelines that came into force 10 years ago.

Members of the Cardiovascular Working Party (CWP) have spent the past three years working on the guidelines that were finalized this week. The process has focused on updating and expanding an earlier, acute heart failure-focused addendum, notably by outlining the patient characteristics that can affect clinical trial outcomes. EMA addresses the need to standardize the time of enrollment, role of composite endpoints and utility of invasive haemodynamic measurements in the document.

Having being finalized and adopted, the guidelines are due to come into force in December. CWP is already well into its next project, namely a pediatric addendum to the acute heart failure guidelines. The addendum addresses areas in which the processes for gathering pediatric data on heart failure drugs diverge notably from those that apply to the broader population. With pediatric studies being hard to run, EMA recommends firms design adult trials to generate data that can be extrapolated.

EMA is accepting comments on the pediatric addendum until the end of November.

Final Guidelines, Draft Guidelines

Other News:

Lord Saatchi’s controversial Medical Innovation Bill is back on the agenda. The bill was vetoed in the last parliament by the Liberal Democrats, the minor party in the ruling coalition. However, with the Liberal Democrats being ousted from power in the recent election, Lord Saatchi is pitching his bill once again. The Spectator

EMA has released a final reflection paper on microbiological aspects of herbal medicines. The paper addresses the tendency for the active ingredients in herbal medicines to have relatively high levels of microbial contamination and outlines some measures manufacturers can take to mitigate the issue. Reflection Paper

The head of the EU drug monitoring agency has downplayed the likelihood of Europe following the U.S. by liberalizing its approach to cannabis. “I do not know any government...that is currently seriously discussing cannabis legalization or regulation,” Wolfgang Gotz said. Reuters

Regulatory Focus newsletters

All the biggest regulatory news and happenings.