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

UK Politicians Advance Bill to Close Drug Pricing ‘Loophole’

Legislation intended to close a drug pricing loophole in the United Kingdom has taken another step forward. The bill is designed to align two medicine price regulation schemes and, in doing so, give the government the power to stop companies from exploiting monopolies on generic drugs.  

The UK runs parallel voluntary and statutory price regulation schemes. Under the voluntary scheme, the government and manufacturers periodically agree to control the prices of branded drugs. The statutory scheme covers manufacturers of branded medicines that choose not to join the voluntary program. This structure has existed for years, but recently the government has identified a flaw in the model. Today, if a company has one drug in the voluntary scheme, all its products are exempt from statutory price controls.

This quirk of the system has rendered the government unable to act when companies have increased the prices of generic medicines. The government leaves market forces to control the prices of generic drugs, but retains the power through the statutory scheme to step in if needed. However, in some situations, both these mechanisms have failed. If a company is the sole supplier of a generic drug and has another product in the voluntary scheme, neither the government nor the market are able to stop it from raising prices. This has enabled companies to sharply increase the price of products.   

“We are aware of some instances where there is no competition to keep prices down, and companies have raised their prices to what looks like an unreasonable and unjustifiable level,” Jeremy Hunt, the secretary of state for health, said during a debate in the House of Commons. “There are companies that appear to have made it their business model to purchase off-patent medicines for which there are no competitor products. They then exploit a monopoly position to raise prices. We cannot allow this practice to continue unchallenged.”

From 2005 to 2015, the prices of 10 generic drugs increased by 1000% or more. The pain medication and antidepressant Doxepin saw the biggest rise. In 2005, its list price was £2.36 ($2.89). By 2015, the price had increased to £124.56, a change of more than 5000%. The prices of six other generic drugs increased by at least 2000% over the same period. The health service felt the effects of these changes in 2015. After a decade in which the annual change in the average price of generics ranged from -17% to 5.1%, last year the figure shot up to 14.4%. The biggest annual change in branded drug prices in the past decade is 5.5%.

The bill is intended to help the government prevent such increases, in part by enabling it to apply statutory controls to companies with drugs in the voluntary scheme. Hunt and other politicians debated the proposal for the second time this week. A detailed examination of the bill by a committee will now take place, after which the legislation will again be debated in the Commons.

Debate Transcript, Commons Analysis

Swissmedic Responds to Discovery of Gaps, Inaccuracies in Data on Manufacturers

The Swiss Agency for Therapeutic Products (Swissmedic) has taken steps to raise the quality of the data it keeps on manufacturers. Swissmedic made the changes after discovering inaccuracies and omissions in the information it keeps on producers of ingredients and finished products.

To date, Swissmedic has revised its manufacturing information form and published an explainer to help companies enter the correct details. Swissmedic has also created a new form for Responsible Persons to use when making declarations. The form is intended to ensure information is submitted to Swissmedic in a standardized format. Swissmedic also sees the form giving it an overview of all of the companies involved in producing a drug.

The introduction of the form marks the start of an ongoing attempt to improve the quality of data at Swissmedic. The regulator will make use of the new manufacturer information form mandatory at the start of December, but is encouraging companies to adopt it before then. If companies discover any errors when compiling their data, Swissmedic wants them to submit an accurate application as soon as possible.

Swissmedic is particularly keen to hear from companies that have failed to submit manufacturers to it for approval in the past. The agency attributes such failings to increased regulatory requirements and a 2013 change to the manufacturer information form. Whatever the reason, Swissmedic thinks its records on which organizations are involved in the production of which drugs are inaccurate. The regulator thinks its data on active pharmaceutical ingredient suppliers are particularly flawed.   

Swissmedic Statement 

EMA Expands SME Advice to Cover Compassionate use, PRIME Scheme

The European Medicines Agency (EMA) has published new advice for micro, small and medium-sized (SME) enterprises. EMA used the revision of its SME guide to add information on compassionate use and its priority medicines (PRIME) program.

Through the guide, EMA intends to give SMEs a single document covering all regulations that affect their operations. As such, the information provided on compassionate use, PRIME and other topics is not new. Rather, the guide centralizes information of relevance to SMEs and points to more detailed resources when necessary.

The new additions to the guide reflect recent changes to EMA regulations and drug development. In the compassionate use section, EMA details when the approach can be taken and clarifies the role of member states. Similarly, the new section on PRIME gives an overview of its benefits and eligibility criteria.  

Other additions to the guide include sections on the imposition of post-authorization measures and the proactive publication of clinical data. The post-authorization section details the obligations, such as the need to run efficacy studies, EMA can place upon companies when approving a drug. EMA sets out its policy on redacting confidential information from clinical reports in another section.

Press Release, User Guide   

Manufacturer Invites to Trial Insulin System Prompt MHRA Warning to Patients

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has learned an organization is contacting patients directly to trial an insulin delivery system. MHRA has responded by advising patients to talk to their diabetes specialist before changing their insulin device.

MHRA has not disclosed the identity of the organization that put the offer of a new insulin system to patients, nor has it provided details of how many people are thought to have been contacted. The agency is taking the situation seriously enough to issue a warning to diabetics about the possible consequences of accepting the offer, though.

“It is vital people use insulin delivery devices which are recommended by their diabetes specialist, and we urge everyone not to make changes to their device or delivery system without first seeking guidance from their specialist,” John Wilkinson, director of medical devices at MHRA, said. “Speak to a qualified healthcare professional if you are unsure or if you have any questions.”

MHRA Statement, More

Other News:

EMA has created a search page to help people find the outcomes of periodic safety update report single assessments (PSUSAs) of nationally authorized medicines. The page sorts active substances alphabetically. Users can also search by active substance or procedure number, as well as filter by the outcome of the regulatory assessment. EMA Notice