Out-Law News | 19 Feb 2020 | 10:16 am | 5 min. read
Life sciences specialist Helen Cline of Pinsent Masons, the law firm behind Out-Law, said the targeted delegated powers provided for in the Medicines and Medical Devices Bill will enable the UK government to "clarify and rationalise the existing frameworks, deliver on the life sciences strategy, and create a UK regulatory framework fit for the future; keeping pace with developments and providing clarity to industry".
"By virtue of the European Union (Withdrawal) Act 2018 the current frameworks governing regulation of human medicines, veterinary medicines and medical devices in the UK, including new pieces of directly applicable EU law that are introduced during the transition period, for example the EU Medical Devices Regulation, will be retained EU law at the end of the transition period," Cline said.
"The targeted powers set out in the Bill will enable the UK government to update the existing regulatory frameworks without the need for primary legislation following the expiry of the Brexit transition period at the end of this year. As proposed these powers will be used to build on the existing frameworks," she said.
The targeted delegated powers permitted by the Bill can only be exercised ... after consideration has been given to safety and availability and the attractiveness of the UK as a place to develop and supply these products
Cline said there is some EU legislation that has been finalised and which will be applicable to life sciences businesses that will not be retained EU law in the UK when the Brexit transition period ends. This includes the In Vitro Medical Devices (IVDR) Regulation, which will not fully apply in the EU until 26 May 2022.
"The UK will be able to make its own decisions about the future regulation of IVDs using the powers proposed in this Bill," Cline said.
"In addition the EU legislation governing clinical trials is due to be repealed and replaced by a new EU Regulation. While this EU Regulation is in force, it is not expected to apply in the EU until after the end of the transition period and therefore it will not form part of retained EU law either. Again it is proposed that the delegated powers under this Bill will be used to make any necessary changes to the UK clinical trial framework," she said.
The Medicines and Medical Devices Bill, first mooted by the government last year, was read for the first time in the House of Commons on 13 February.
Public Policy Manager
Any company or organisation wishing to engage in shaping the legislation should be forming an early view on how this Bill might impact its business operations
Public policy expert Mark Ferguson of Pinsent Masons said: "The Bill will now proceed to second reading in the House of Commons, which is the first opportunity MPs will have to scrutinise the main principles of the legislation. Though specific amendments cannot be proposed at this stage, MPs will have the opportunity to raise any significant concerns they may have with the Bill, in order to put down a marker for potential amendments later in the legislative process."
"As the first major piece of post-Brexit legislation affecting the life science and pharmaceutical sector, the Bill will be closely monitored by industry. Any company or organisation wishing to engage in shaping the legislation should be forming an early view on how this Bill might impact its business operations, and may want to consider acting now to engage in the parliamentary process," he said.
Government powers to set out regulations in relation to medicines under the Bill include rules concerning the manufacture, import and distribution of both human and veterinary medicines. The government would also have the power to update existing rules concerning marketing authorisations, labelling and packaging requirements, and medicines advertising too.
The government's powers under the Bill would also extend to lifting existing prohibitions concerning the sale or supply of both prescription only medicines and human medicines not subject to general sale, and the Department of Health and Social Care has suggested it would use those powers to "increase the range of professions able to prescribe medicines in low-risk circumstances".
Those rules, which the department said would be subject to "safeguards and limits", would save patients' time, cut down on unnecessary doctor appointments and allow the NHS to "make the best use of its highly skilled workforce". The government said it would work with the NHS and others to "determine what medicines could be eligible and in what circumstances".
The Bill also provides the government with the power to lay down rules on falsified human medicines too.
Cline said: "At the end of the transition period the EU falsified medicines regime will no longer apply to the UK. The Bill permits the introduction of regulations to prevent the supply of falsified medicines, and to allow any information that is collected for the purpose of the prevention of the supply of falsified medicines to be used, retained and disclosed for any purpose to do with human medicines."
On medical devices, the Bill provides that new regulations could set out requirements for the devices to be marketed, put into service or otherwise supplied. This includes potential new rules concerning the design, manufacture, composition or other characteristics of the devices, or those imposed on persons involved in marketing or supplying the devices. The regulations might also address assessments of compliance with the requirements, including who may carry out such assessments, while provision could also be made for a medical devices register to be established and for investigations into or evaluations of the safety or performance, including the clinical effectiveness, of medical devices.
Further provisions concern the enforcement of medical device law, and provide scope for UK regulators to restrict the availability of a medical device in order to protect health or safety, and require businesses to disclose information and produce documents in certain circumstances.
It will be an offence to breach one of the notices the regulator will be able to serve under the new framework, although businesses that can show they "took all reasonable steps and exercised all due diligence to avoid commission of the offence" will have a defence against the offence.
The regulator will also have powers to impose product recalls where it "considers that it is necessary to restrict the availability of a medical device in order to protect health or safety, and the device has already been supplied or made available to members of the public". In addition, regulators will be able to apply to court for "an order for the forfeiture of a medical device" if they believe there has been a breach of medical device laws in respect of the device.
The government also has powers under the new Bill to issue public health warnings in respect of the safety of medical devices and to share information with industry in relation to medical devices and prohibit industry from further disseminating that information. Individuals placed under a duty of confidence in this regard face potential imprisonment if they use of disclose the information except in a way which is agreed with government or sanctioned by a court.
The government can also fine businesses for non-compliance with a regulator enforcement notice, and can also accept undertakings regarding the continuation or recurrence of offences.
Cline said: "The targeted delegated powers permitted by the Bill can only be exercised on an exhaustive list of matters outlined in the draft legislation and then only after consideration has been given to safety and availability and the attractiveness of the UK as a place to develop and supply these products, and also generally only following consultation."
"To some degree at least changes to existing frameworks will be determined by future developments as well as by the outcome of the continuing UK-EU negotiations," she said.
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