Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Hurries Through Drug Pricing Bill Before Parliament Closes for Snap Election
Politicians in the UK have hurried through drug pricing legislation before Parliament closed ahead of a snap general election. The calling of the surprise election created a deadline for resolving a dispute between the two houses of the UK Parliament, prompting politicians to create a compromise amendment considering the economic consequences of pricing decisions.
Prior to the calling of the election, the draft legislation had passed back and forth between the House of Commons and the House of Lords without the two sides reaching an agreement on the inclusion of a particular amendment. The House of Lords wanted to add text to the bill that forced the government to either “have regard for” or “take account of” the need to promote and support the life sciences industry when purchasing medicines and medical supplies. The amendments were intended to allay industry concerns about the bill and show government support for the sector.
Members of the House of Commons, notably politicians in the ruling Conservative party, rejected both versions of the Lords’ amendment. The rejections reflected concerns the wording of the text would hinder the government’s ability to effectively control the cost of drugs. Senior politicians also warned the amendments would leave the government open to legal challenges if its pricing decisions failed to promote and support the life sciences industry.
Originally, the House of Commons rejected the amendment without proposing alternatives, but its position changed when UK Prime Minister Theresa May called the election. May’s action meant parliament would close on May 3.
Responding to the new, closer deadline for passing the law, politicians in the House of Commons proposed an amendment to address the Lords’ concerns without compromising the government’s ability to control drug prices. The amendment states government consultations about the use of powers enabled by the bill must include discussions of the economic consequences for the UK life sciences industry. Discussions must also cover the consequences for the broader economy and patients.
“The requirements are framed in this way in order not only to consider the economic consequences for the life sciences industry and for patients who may benefit from new medicines but to balance these factors against wider considerations. I am sure that we can all agree that, although a thriving life sciences industry and access to new medicines are highly desirable, it must not come at any cost and it is the government’s responsibility to achieve the right balance and to
be held to account for it,” Lord O'Shaughnessy said in a debate about the amendment.
Passage of the bill means the government that is in charge after the election will have the power to prevent companies from exploiting monopolies on generic medicines. The old pricing system allowed companies to increase what they charged for some generic drugs by up to 5000% from 2005 to 2015. The new text is designed to prevent such price increases by empowering officials to apply statutory controls to drugs in the voluntary scheme.
As it stands, it appears likely the government that gains those powers after the June 8 election will look a lot like the current government. Polls suggest Theresa May is on course to significantly add to the majority her party has in the House of Commons.
Amendments, Debate Transcript
France Maintains Restrictions on Docetaxel After Analyzing Adverse Events
Regulatory officials in France have maintained the restrictions they placed on the use of docetaxel despite EU-level data showing no increase in the rate of adverse events. The decision follows a review of the cases of neutropenic enterocolitis that prompted the regulator to halt the use of the drug in non-metastatic breast cancer in February.
Analyses performed by the French National Cancer Institute (INCa) and the National Agency for the Safety of Medicines and Health Products (ANSM) found no fault with the quality of any brand of docetaxel sold in France and no association between particular products and the adverse events. A separate analysis performed by the Pharmacovigilance Risk Assessment Committee (PRAC) failed to find evidence the frequency of adverse events at the EU level has increased over the past two years. Neutropenic enterocolitis is a known but rare side effect of docetaxel use.
The findings suggest the cases of neutropenic enterocolitis seen in France may be an unfortunate but routine result of docetaxel use, rather than evidence of a wider change in its adverse event profile or fault with one particular formulation of the active ingredient.
Officials in France are continuing to investigate the matter, though. Work to characterize the risk profile of docetaxel is ongoing. In parallel, pharmacovigilance researchers are looking at the safety profile of paclitaxel, another chemotherapy drug also used to treat breast cancer. The research is expected to lead to INCa recommendations on best practices for using docetaxel and paclitaxel in the coming months.
Until the research is complete and the recommendations are made, ANSM will continue to advise against the use of docetaxel in certain types of breast cancer. This precautionary position differs from that adopted by the European Medicines Agency’s PRAC, which advised doctors to continue using docetaxel in line with the product label when it established its preliminary position in March. PRAC is due to discuss the findings of its more thorough assessment of the situation next month.
ANSM Notice (French)
European Pharmacopoeia Rushes in Revised Antibiotic Monograph to Avoid Shortage
The European Pharmacopoeia has rushed in a revised version of the erythromycin ethylsuccinate monograph. Officials brought the new version into force on 1 May in response to fears the test for related substances could lead to a shortage of the antibiotic.
Implementation of the monograph is the latest event in a turbulent five months for the document. The European Directorate for the Quality of Medicines (EDQM) brought in version 9.0 in January, only to quickly start receiving feedback about problems with the related substances test. Officials concluded the problems with the text could affect the supply of the antibiotic and as such took action.
Last month, EDQM proposed rolling back to the test included in version 8.0. That change has now happened. The latest, 1 May version of the monograph is the same as version 9.0 except it features the older, 8.0 test for related substances. Switching to the old test is intended to head off issues that could affect the supply of erythromycin ethylsuccinate.
The action buys EDQM some time to review the test included in 9.0 and assess what approach will work best in the long term. Future changes will go through the normal procedure to allow people to comment on the amendments.
Swissmedic Notice (French), EDQM Alert
Germany has adopted a risk-based approach to the identification of supply bottlenecks. The Federal Institute for Drugs and Medical Devices (BfArM) has created and released a list of active pharmaceutical ingredients of particular importance. Officials have also identified which products lack therapeutic alternatives. These critical products will be subject to stricter monitoring. BfArM Statement (German)
Roche has revised its advice to users of Accu-Chek Insight insulin pumps. The company’s new position is intended to prevent the rapid battery depletion and unexpected shutdowns some users have experienced. MHRA Notice