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Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA has alerted healthcare professionals to a shortage of Bristol-Myers Squibb's kidney transplant drug Nulojix. The drug shortage is set to last until the end of the year, or longer if Bristol-Myers' implementation of a new manufacturing process takes more time than anticipated.
Bristol-Myers is aiming to transition to the new manufacturing process for Nulojix by the end of the year. In the meantime, its output of the powder has fallen below the level needed to meet demand. Nulojix is a powder containing the active ingredient belatacept that is formulated into a solution for intravenous delivery to kidney-transplant patients.
EMA approved the drug in 2011 on the strength of data linking it to improved patient and organ survival in people undergoing kidney transplants. The drug is designed to achieve these outcomes by suppressing the activity of T cells and, in doing so, preventing rejection of transplanted kidneys.
Now, with supplies of Nulojix constrained for nine months or more, no new patients will be able to receive the drug. Healthcare professionals are advised to restrict use of Nulojix to patients who are already being treated with the drug and provide alternative therapies to everyone else.
The United Kingdom government has outlined its opposition to indication-specific drug pricing. A politician from the opposition Labour party has asked two questions this year about the potential to adopt an indication-specific pricing model, but the government is against the idea.
Detailing the government's position in January, the Department of Health's Nicola Blackwood said initial assessments suggest indication-specific pricing would have "significant long-term financial and operational implications for the National Health Service." This week, Blackwood fleshed out the government's reasoning in response to a follow-up question.
Blackwood said setting multiple prices for the same drug depending on the target indication would stop companies from offering discounts to ensure their products are recommended for use in "less-effective indications." The government predicts this would drive up healthcare costs.
Officials also foresee the model increasing costs indirectly. Under the pricing model, the healthcare system w
Government Response, Original Question
Politicians in the United Kingdom have rejected a proposed amendment to a drug pricing bill that would have enshrined government support for the life sciences sector into law. The government successfully opposed the proposal on the grounds it would empower companies to challenge any actions it took to control costs.
Members of the House of Lords, the second chamber of the UK parliament, added the amendment to allay industry concerns about the drug pricing bill. Some Lords saw the bill as running counter to the government's statements of support for life sciences and, as such, wanted to change the text to provide reassurance. The amendment stated the government "must have full regard" to the need to "promote and support a growing life sciences sector."
The House of Lords voted in favor of the amendment by 253 to 208 last month, only to see it rejected by a narrow margin in the House of Commons this week. With the ruling party coming out against the proposal, the Commons voted against the amendment by 288 to 241.
Outlining the government's opposition to the amendment, the Department of Health's Philip Dunne said: "The amendment would undermine one of the core purposes of the bill by hindering the ability of the government to put effective cost controls in place. Having such a requirement in legislation could encourage companies to bring legal challenges where the cost controls have not, in themselves, promoted growth in the life sciences industry. That could significantly hinder the government's ability to exercise their powers to control costs effectively."
The Commons agreed to the other 23 amendments proposed by the Lords. Those amendments include changes relating to the remuneration of people providing special medicinal products. These individually produced medicines can carry prices tags one politician described as "eye watering." The amendments allow for regulations that tie specials remuneration calculations to the outcome of prescribed procedures.
Amendment Rejection, Debate Transcript
The Committee for Medicinal Products for Veterinary Use (CVMP) cut the number of minor use, minor species (MUMS) drug applications that received financial incentives again last year. CVMP awarded financial incentives to one of the 18 successful MUMS applications, a new low, but it still saw the cost of the scheme rise.
Efforts to restrict the number of MUMS applicants that are eligible for financial incentives began in 2013, when the European Medicines Agency (EMA) changed the acceptance criteria. That change limited the incentives to drugs for use in food-producing animals. Moving to this new model led to a decline in the number and proportion of applicants that receive financial support. Having peaked the year before the restrictions came into force—when 16 out of 20 MUMS recipients got financial support—the figures have trended downward in recent years to the 1 in 18 reported in 2016.
When EMA adopted the restrictions, some observers raised concerns the change would diminish the attractiveness of MUMS, a program set up to stimulate research in neglected areas of the animal health market. Results since then have shown the concern to be unfounded. Rather than fall away, the number of new MUMS applications has stayed around and above the 20-plus a year CVMP received before adopting the restrictions.
The cost of the scheme has been similarly unaffected by the restrictions. EMA calculated the cost of MUMS in terms of waived and reduced fees in 2016 to be approximately $320,000. Last year, EMA reported the cost to be in the range of $150,000, while in 2014 the number was $260,000. EMA offered no explanation for the rise in costs. The previous year, 2015, was an outlier in terms of the number of companies that received financial incentives, though, with the seven applicants that secured support that year far exceeding the numbers for 2014 and 2016.
While CVMP is struggling to bring the cost of the scheme down, it is making steady progress in other areas. Last year saw CVMP recommend four medicines with MUMS status for marketing authorization. The batch included the first DNA vaccine to win approval in the European Union and a medicine to protect honey bees against a parasite.
EMA's management board endorsed the 2016 MUMS report at its March meeting.
CVMP Report, Meeting Highlights
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has changed its guideline on registering to sell drugs online and display the EU common logo. MHRA's changes affect a section on selling from the UK to other countries in the European Economic Area. The new version clarifies the product must be approved in the destination country and use the authorized packaging and language. MHRA Guidance
The Committee on the Environment, Public Health and Food Safety has approved the European Council's position on changes to the regulations covering in vitro diagnostics and medical devices. Draft Recommendation
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