Opinion Article | Open Access | Published ?
Introduction of the UK Medicines and Medical Devices Bill
On February 13 2020, the Medicines and Medical Devices Bill (“The Bill”) was introduced to the House of Commons and puts into place the necessary tools for the UK to achieve the government’s vision for a world-leading system of medicines and device regulation.
According to the government, the Bill’s purpose is to support the growth of the domestic life sciences sector ensuring that the UK remains at the forefront of the global life sciences industry. Patients will have faster access to innovative medicines such as personalised medicines to improve patient treatment plans, and the UK will take a lead in global research in areas such as rare diseases.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) will be able to develop innovative medical technology regulations to enable early access to cutting edge technologies including artificial intelligence and break new ground in complex clinical trials.
The new Bill will confer powers to amend or supplement the laws relating to human medicines, veterinary medicines and medical devices following the United Kingdom’s departure from the European Union. The Bill will also allow for provisions to be made concerning the enforcement of regulations, the sharing of product safety information and the introduction of new sanctions with regard to medical devices.
The introduction of the Bill is necessary as once the UK reaches the end of the current transition period on December 31 2020, section 2(2) of the European Communities Act (ECA) which confers a power for EU legislation to be transposed into UK law through domestic regulations will no longer apply. In the absence of section 2(2) ECA, the powers to amend the UK regulatory schemes for human medicines, clinical trials or veterinary medicines will be though the enactment of UK primary legislation.
In relation to certain aspects of medical device regulation, primary legislation is also required to update the regulatory scheme which is made by jointly applying section 2(2) of the ECA and section 11 of the Consumer Protection Act 1987 (CPA). The Bill enables the government to disapply the CPA and the amendments to the UK Medical Device Regulations 2002, and will afford the power to issue enforcement notices for medical devices contained solely in the Bill.
Outlined below are key regulatory elements introduced by the Bill concerning human medicines, veterinary medicines and medical devices.
1. The prescribing of medicines
The Bill will increase the range of professions able to prescribe medicines in low-risk circumstances. Currently, for example, midwives and paramedics can prescribe pain relief thus reducing reliance on GP appointments. The Bill will allow 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.
2. Accelerated patient access to medicines
Accelerated access to medicines is a prominent feature of the government’s future plans in an effort to streamline access to treatments for patients. The Bill confers powers that allow the government to make it simpler for hospitals to trial and manufacture innovative personalised 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.
3. Clinical Trials
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. The MHRA and the 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.
4. Falsified Medicine
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 clear if the UK will continue to have access to this database post the transition period.
5. Registration Scheme
The 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.
1. 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.
2. New Civil Sanctions
The system of enforcement for breach of medical device regulations will be simplified and strengthened. The Secretary of State shall be provided the ability to impose new civil sanctions in the form of a monetary penalty or the enforcement of an undertaking as an alternative to criminal prosecution of offences. The Bill also introduces the creation of a bespoke criminal offence which will clarify which contraventions of the MDR 2002 could result in prosecution.
3. Requirements for the manufacture, marketing and supply of a medical device
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 Organisation for Standardization (ISO)) and agreements (such as mutual recognition) being used as a reference to identify such requirements, it remains 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.
1. 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.
2. Selling of medicines online
The 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.
3. Labelling and Packaging of medicines
New regulations could be created to update existing labelling standards of medicines and introduce new requirements such as pictograms to replace or supplement some of the written labelling on medicines.
The new Bill provides an initial insight which suggests that the UK regulatory landscape for medicines and medical devices will not diverge significantly from existing EU legislation. The Bill offers regulatory additions to that of current legislation such as the expansion of medicine prescribing, the fostering of innovative patient treatment plans, increased autonomy for regulatory authorities and the softening of regulatory obstacles for low risk clinical trials.
However, as 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, it is most likely that future legislative developments will occur in the medicines and medical devices sector following the Brexit transition period in efforts to maintain global regulatory relationships.
Authors: Cliodhna McDonough, Regulatory Life Science lawyer & Legal director