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Cliodhna McDonough is a life sciences lawyer at Fieldfisher.
The Medicines and Medical Devices Bill was recently introduced to the UK House of Commons. Does it provide the confidence that the UK is still a leading country for life sciences? Cliodhna McDonough reports.
The Medicines and Medical Devices Bill was recently introduced to the UK House of Commons. But does it actually provide the confidence that the UK is still a leading country for life sciences?
There’s no doubt that the bill did indeed give those within the life sciences sector a spout of excitement, which was much needed after constant rhetoric around the impact of Brexit and fears over organizations having to move operations elsewhere. So let’s look at the initial promises regarding human medicines, medical devices and veterinary medicines.
The bill did announce that patients will have faster access to innovative medicines such as personalized medicines to improve patient treatment plans, and that the UK will take a lead in global research in areas such as rare diseases. While, in compliance with EU legislation, clinical trials in the UK face many hurdles that can cause delays in getting a product onto the market, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) will be able to develop innovative medical technology regulations. These will enable early access to cutting edge technologies, including artificial intelligence, and break new ground in complex clinical trials.
Furthermore, the bill confers powers that allow the government to make it simpler for hospitals to trial and manufacture innovative personalized medicines. Hospitals will be able to use patient tissue and DNA samples to tailor treatments to individual patients when other medicines have failed, or to develop medicines that have a shelf-life of minutes and would otherwise be unavailable.
The bill will expand the range of medical professionals who are able to prescribe medicines in low-risk circumstances. Allowing, the government to work with the NHS and stakeholders in order to determine additional types of staff who could prescribe with safeguards in place and limits on what medications are eligible.
The bill will allow the government to deliver the same effects as certain elements of EU regulations on clinical trials, in future UK clinical trials legislation, if it is deemed that this will help ensure that the UK maintains a leading approach to clinical trials.
Based on concepts of proportionality and risk, existing trial notification and reporting requirements could either be amended or “unnecessary bureaucracy for the lowest risks clinical trials” removed. MHRA and VMD will be afforded powers to develop regulations that will promote early access to innovative technologies and facilitate clinical trials. This will assist researchers and companies to rapidly trial new medicines whilst ensuring consistency with best practice and global standards.
As is similar in EU legislation, the bill provides for the inclusion of “a scheme to combat counterfeit medicines entering supply chains” such as the inclusion of unique identifiers and anti-tamper devices on packs. Currently, pharmacies in the UK have access to the EU falsified medicines directive database, which alerts pharmacists to counterfeit medicines in the supply chain. However, it is not yet clear if the UK will continue to have access to this database post the transition period.
MHRA currently requires online sellers of general sales list prescription-only medicines or pharmacy medicines to register for a “Distance Selling Logo” to help members of the public to identify websites that can legally sell medicines. Provisions in the bill allow for the introduction of a new registration scheme for online pharmacies requiring persons who sell medicines to notify the MHRA. Changes to information detail(s) to be included in online prescriptions and the types of prescriptions that may be sent electronically may also be introduced.
UK Register of Medical Devices
A UK register for all medical devices, their manufacturers or their suppliers will be introduced. Companies will need to register medical devices with the MHRA ensuring suppliers follow strict safety checks. In addition, some or all of the register information entered could be made publicly available subject to data protection.
The fear of being caught up in a contentious dispute is a real worry for many organizations. Well, the new bill has promised to simplify and strength the current system of enforcement by bringing together enforcement rules for breach of medical device regulations under one legislative umbrella. The Secretary of State will be allowed to impose new civil sanctions in the form of a scheme of enforcement notices with the creation of a bespoke criminal offence for breach of these enforcement notices. The bill allows for civil proceedings to be brought by individuals affected by a breach of medical device legislation and the defence of due diligence may be available for those accused of an offense.
The business of medical devices
The bill allows for provisions to be made, with regards to the requirements that must be met before a medical device can be placed on the market, put into service or supplied in the UK. In line with existing EU legislation, confirmation that such requirements have been met and to what standard will also be necessary. Whilst, the Bill refers to international standards (presumably the International Organization for Standardization (ISO) and agreements (such as mutual recognition) being used as a reference to identify such requirements, it does however, remain unclear whether additional regulatory hurdles outside of existing EU regulations will be introduced.
In addition, the Health and Social Care Secretary will be given the power to disclose specific information about devices to members of the public and health care systems, subject to appropriate safeguards when there are serious patient concerns.
Prescribing of veterinary medicines
Presently, the Veterinary Medicines Regulation 2013 lists which groups of professionals have the appropriate qualifications to prescribe certain categories of medicines. Over time, the roles of staff within the veterinary industry will evolve and certain professionals may be added or removed from this list by amending regulations.
Selling of medicines online
VMD currently operates a voluntary scheme that accredits UK based retailers who sell veterinary medicines on the internet. The bill allows for mandating registration of persons who sell medicines online and attach certain conditional registration requirements.
Labeling and packaging of medicines
New regulations could be created to update existing labeling standards of medicines and introduce new requirements such as pictograms to replace or supplement some of the written labelling on medicines.
The Medicines and Medical Devices Bill includes many similar provisions to current EU legislation but loosens the reigns in needed areas. The expansion of the number of medical professionals that with authority to prescribe; the ability to get products on the market quicker; increased autonomy for regulatory authorities; the softening of regulatory obstacles for low-risk clinical trials; and the introduction of civil sanctions for medical devices appear to be essential elements to adding much-needed vibrancy to the UK life sciences sector post-Brexit.
However, the government has stated medical devices will be “subject to the highest standard of regulation” and in the absence of published complementary technical guidelines, it is unclear yet as to whether additional regulatory hurdles will apply to the UK medical device sector.
Overall, in efforts to maintain global regulatory relationships, the post-Brexit transition period will likely see future legislative developments in the medicines and medical devices sector.
Cliodhna McDonough is a life sciences lawyer at Fieldfisher.
1. Medicines and Medical Device Bill: Memorandum from the Department of Health and Social Care to the Delegated Powers and Regulatory Reform Committee.
2. Medicines and Medical Devices Bill 2019-20.
3. Medicines and Medical Devices Bill 2019-20. Explanatory Notes.