Clause 5 provides that changes can be made to the law relating to human medicines with respect to fees, criminal offences and the powers of inspectors. Regulations made under clause 1(1) allow us to change the UK’s regulatory framework for human medicines as science, technology and clinical needs evolve. When the regulatory regime is updated, it is important that the regulator—in this case, the MHRA—can continue to regulate effectively and maintain compliance with all elements of the regime. To ensure this, it may be necessary to make provision about charging fees, creating criminal offences, and updating inspectors’ powers when making changes to the regulatory regime. Regulations made under clause 1 and relying on clause 5 will enable us to do this. We will consult before making any of those changes.

Clause 5(1)(a) allows us to make provision about the charging of fees. The regulator is self-funding for the purposes of medicines regulation. This work includes assessment for marketing authorisations and clinical trials of human medicines and inspections. It is funded by fees payable by the pharmaceutical industry in relation to the services and regulatory work provided. The current fees are set out in the Medicines (Products for Human Use) (Fees) Regulations 2016 and vary according to the specific areas of work.

It is important that existing fees can be amended, or fees can be introduced in connection with the MHRA exercising functions conferred by human medicines provisions as they evolve. Any proposal to introduce new fees is subject to consultation. The impacts on industry, Government and the general public would be evaluated through the usual process of an impact assessment. As part of its regulation of human medicines, the MHRA is able to impose criminal sanctions for certain regulatory breaches. As the regulatory regime is updated in future, it is important that we have the ability to also update the corresponding list of offences against which the MHRA can take action.

Clause 5(1)(b) allows us to create criminal offences with a maximum of two years’ imprisonment to cover updated requirements to supplement the evolution of the regulatory regime. MHRA inspectors play a critical role in ensuring compliance so that medicines are safe and effective for patients, and so that manufacture, research and surveillance processes are carried out to recognised standards. Inspectors already have all the powers to enter premises at any reasonable time to determine whether there has been a contravention of medicines regulations. For example, they may take samples or copies of documents if it is suspected that an offence has been committed. We have published two illustrative statutory instruments to demonstrate how provision can be made in regulations, relying on clause 5(1)(b) in combination with subsections of clause 2, to create a criminal offence for failing to comply with the new requirement set out in the regulations.

Clause 5(1)(c) allows us to update the relevant powers of entry and other powers of inspectors to align with new elements of the regulatory regime as it evolves. I commend the clause to the Committee.