European Regulatory Roundup: EU Council Presidency to Prioritize Drug Availability Eisai, IQWiG Clash Over Halaven (8 September 2016)

Regulatory NewsRegulatory News | 08 September 2016 |  By 

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

UK Commits to Personal Data Sharing Plan Following Review of IT Regulations

The United Kingdom has committed to creating a personal health data sharing system inspired by the Blue Button approach used in the United States. Government officials unveiled the plan following an independent review of healthcare IT in the UK that called for changes to data-sharing regulations.

In response to the report, the government has promised to give individuals "instant access" to their health records online. Once operational, the system will enable people to download their health data from the NHS.UK website. The government highlighted prescriptions and test results as two types of information that will be accessible through the system, but, in explicitly citing the Blue Button as the inspiration for the model, it has also suggested the approach could address interoperability and data-sharing recommendations made in the healthcare IT review.

The sharing of healthcare data in human and machine-readable formats is central to the Blue Button. These topics are covered in the independent review of the National Health Service's IT infrastructure. Having assessed the situation, the authors are calling on the government to ensure the IT system and the data it handles are interoperable. This is a far-reaching recommendation. The need to develop a regulatory framework for data sharing is among the more defined and pressing priorities. This is seen as necessary for both healthcare and research. 

"Data sharing should also support research," the report's authors wrote. "One can envision a single point of entry to NHS England's data, which is made available to researchers and others working on problems deemed high priority by NHS and the Department of Health."

The UK has encountered resistance when trying to implement information-sharing initiatives, notably when it botched the rollout of, but the desire to use its cradle-to-grave data repositories to support research remains strong. That said, the report's authors limited their deliverables to the more prosaic, though no less important, tasks of making sure different parts of the UK's healthcare system can share data internally. The goal is to make systems in each region interoperable by 2020.

Press Release, IT Report

Presidency of EU Council Prioritizes Improvements to Drug Availability

The Slovak presidency of the EU Council of Ministers has identified improvements to the availability of drugs as a top priority for its time at the head of the organization. Slovakia is setting the agenda at the Council until the end of the year, giving it several months in which to advance its ambitions.

Slovak ministers communicated their desire to improve medicine availability at a series of meetings that have been held since the country took over the presidency in July. The ministers inherited many priorities, including that of drug availability, from their predecessors from the Netherlands, who held the presidency between January and July, but reports of Slovakia's objectives for its presidency suggest it will increase the focus on access to medicines.

Talking to the Committee on the Environment, Public Health and Food Safety, Tomáš Drucker said drug availability is "a critical issue for patients and growing problem in Europe." The Dutch also listed drug availability as a priority, but it was given less prominence in reports of their plans for the presidency. Drucker, who became Slovakian minister of health earlier this year, sounds keen to intensify efforts. Prior to the appointment, Drucker spent four years as CEO of state-owned postal service Slovak Post.

The Slovak presidency will need to fit the drug availability discussions in around other priorities. Talks about medical devices that predate the Slovak presidency are ongoing and likely to be a primary area of focus. The Slovaks have also inherited an interest in veterinary medicines, although they look set to focus more on legislation of the sector in general with a view to gaining a mandate to start negotiations with Members of the European Parliament. Antibiotics were the top Dutch priority.

Presidency Priorities

Eisai Clashes With IQWiG Again After Cost Watchdog Rejects Cancer Drug

Eisai has clashed again with the German Institute for Quality and Efficiency in Health Care (IQWiG). The latest flashpoint involves a IQWiG report that found Eisai's Halaven offers no additional benefit in unresectable advanced or metastatic liposarcomas over established comparator therapies.

After reading the report, Eisai published a press release expressing bewilderment at the findings. The Japanese drugmaker is accusing IQWiG of ignoring pivotal Phase III data on Halaven, also known as eribulin. Eisai said the data show Halaven to be the only single-agent therapy to significantly improve overall survival in patients with advanced liposarcoma, a type of soft tissue carcinoma that originates in fat cells.

The company is vocally unhappy about the decision. "Eisai cannot understand the suggestion of the IQWiG that no additional benefit has been proven for eribulin, despite compelling phase III data which show an overall survival benefit. We are hopeful that, notwithstanding the report by IQWIG, the [Federal Joint Committee] (G-BA) will take a more informed view," Patrik Höller, director of the oncology business group at Eisai's German unit, said.

Eisai has a track record of releasing strongly worded statements in response to the findings of health technology assessment (HTA) bodies such as IQWiG. This week's statement about being "bewildered" about the IQWiG rejection comes two years after Eisai fired off a release to say it was "outraged" about the conclusions of a review of an epilepsy drug. Eisai has also repeatedly threatened to make cuts at its UK operation in protest against National Institute for Health and Care Excellence decisions.

Press Release

Novo Nordisk Recalls Emergency Diabetes Drug in Response to Needle Defect

Novo Nordisk is recalling batches of an emergency diabetes drug from the UK after detecting a fault with some of the needles. While the defect is rare, the potential for it to stop the drug being used to address severe low blood glucose in an emergency has led the company to recall the seven batches.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued a press release and alert to make the public and healthcare professionals aware of the issue, which affects emergency hypoglycaemia product GlucaGen HypoKit. In some cases, the needle has become detached from the syringe, a failing that makes the product unusable and would lengthen the time it took for a patient to receive the emergency medication.

Novo Nordisk estimates the problem affects 0.006% of the needles. "Whilst only a small number of these kits are affected by this fault it is important that people are confident their treatment will be effective in the event of emergency," Gerald Heddell, MHRA's director of inspection, enforcement and standards said. "People with these kits should check which batch their kit is from and, where necessary, get a replacement from a pharmacist."

Heddell wants anyone who has issues with the product to report the fault to MHRA through its Yellow Card scheme.

MHRA Alert, Press Release

Other News:

MHRA has issued a warning about Roche's Accu-ChekInsight insulin pump system. The warning relates to "inadequately detailed handling instructions" that could result in patients receiving unwanted doses of insulin. Specifically, MHRA is concerned users may be unaware that the "Quick Bolus" keys are not affected by a feature that locks the insulin pump. Press Release, More


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