Three UK-based health groups have warned that Brexit could result in British patients, researchers and government agencies losing access to the results of medical research, endangering patient safety and undermining future decision-making by the NHS.
HealthWatch UK, Universities Allied for Essential Medicines UK, and TranspariMED on Friday warned the House of Commons Health Committee’s inquiry into Brexit that:
"Brexit could strengthen or weaken existing transparency provisions in the regulation of clinical trials in the UK. The current regulatory framework pertaining to clinical trial transparency consists of a mixture of UK and EU regulations and rules.
As a consequence of incomplete and inaccurate reporting, patients are harmed, public health agencies cannot make informed decisions, public health funds are wasted, medical progress is slowed down, and shareholders are exposed to unnecessary risks. Examples include Lorcainide, a drug that killed over 100,000 people over the course of a decade, Tamiflu, on which the NHS seems to have misspent £424 million, and Vioxx, whose withdrawal after concealed safety concerns led to shareholder losses of $37 billion."
At present, EU regulations mandate that the summary reports of many clinical trials are made public within 12 months, and allow UK scientists and government agencies to access detailed Clinical Study Reports that reveal details about the positive and negative effects of new drugs coming onto the market.
Image credit: European Pharmaceutical Manufacturer magazine
Unless policy makers pay attention, the health groups warn, this access to potentially life-saving information could be lost post-Brexit.
In order to put patient safety and evidence-based decision making first, the post-Brexit regulatory framework for pharmaceutical research needs to incorporate the following features:
Adherence to trial registration and summary results posting provisions should be actively monitored through a National Clinical Trial Audit System. A pilot has proven the feasibility of setting up such a system in the UK. It would cause no delays for institutions conducting clinical trials in the UK and, since its work would be based on records that already exist, it would cost little to set up and run.
Any post-Brexit institutional and regulatory framework should make access to all relevant Clinical Study Reports a pre-condition for permission to market any drug in the UK, including continued permission to market any and all drugs that are currently in use in the UK. Access to these Clinical Study Reports should be given to all UK government agencies (including, but not limited to, the MHRA and NICE) as well as all UK-based academic and private sector researchers.
To better protect patients based on the full extent of available data, post-marketing surveillance (PMS) data should be made publicly available.
For more details, please see the written evidence submitted jointly by HealthWatch UK, Universities Allied for Essential Medicines UK, and TranspariMED to the House of Commons Health Committee’s inquiry into Brexit.