The new human medicines regulations consolidate decades worth of British legislation, making the law easier to understand, say Olya Melnitchouk and Alison McAdams

Medicine

On 14 August, the human medicines regulations 2012 (S1 2012/1916) came into effect, replacing most of the Medicines Act 1968 and about 200 statutory instruments with a simplified set of rules.

They are the result of the Medicines and Healthcare Products Regulatory Agency’s consolidation and review of the UK’s medicines legislation.

The new regulations implement European directive 2001/83/EC relating to medicinal products for human use (the medicines directive). The new regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. 

The regulatory agency’s chief executive, Professor Sir Kent Woods, has said the new regulations “will simplify 40 years of legislation, much of which has become outdated and fragmented”.

The agency expects consolidation will make medicines laws easier to use, reducing the burden associated with understanding and complying with the requirements, while maintaining strong and effective safeguards for public health.

Policy changes

There have been some policy changes introduced with the new regulations. For example, legislation previously required standardised statuory warnings in prescribed form to be included in the labelling and product information leaflets for certain over the counter drugs, so as to ensure warnings were consistently clear for products with the same active ingredient. Statutory warnings have now been removed by the new regulations for most of these types of products. 

In place of the statutory warnings, the agency will rely on the inclusion of warnings specific to products or classes of products as terms of marketing authorisations.

‘The regulations introduce greater involvement of patients and healthcare professionals in reporting medicine safety issues’

The explanatory memorandum to the new regulations says: “This will allow warnings to reflect the results of user testing and be changed without the need for legislative action, and will avoid the burden of recalling medicines from the supply chain when warning requirements in legislation are changed.”

The statutory warnings will remain in place for paracetamol due to the particular risks it poses in relation to overdose, to ensure the use of consistent warnings across the wide range of paracetamol-containing products.

Another policy change is to allow pharmacists to make changes to a prescription relating to the name of a product or its common name, directions for use of the product and precautions relating to use, without the need to contact the prescriber. This allows pharmacists to make use of their professional judgment and expertise more efficiently.

Other policy changes introduced include:

  • enabling former members of medicines advisory bodies to be appointed to review panels for agency licensing decisions, providing that one year has elapsed since their term of office on any such body has expired;
  • updating of sale, supply and administration exemptions in order to reflect modern clinical practice;
  • changes to the process by which independent hospitals, clinics and agencies are able to use patient group directions, which are written directions for the sale, supply or administration of a description or class of medicines to persons generally, to ensure processes reflect changes to the registration requirements for organisations;
  • the repeal of section 10(7) of the Medicines Act, which allowed pharmacists to wholesale deal small quantities of medicines without a licence (however, the regulator has given advice to pharmacists to ensure that appropriate supply of medicines within the healthcare service can continue).

Introducing pharmacovigilance

The regulations also implement European directive 2010/84/EU, which introduces new pharmacovigilance requirements.

The directive establishes clear roles and responsibilities for marketing authorisation holders and for regulators. It also introduces greater involvement of patients and healthcare professionals in reporting safety issues arising from the use of medicines. 

The agency believes the new provisions introduce “a strengthened, clarified and more proportionate regime for pharmacovigilance to ensure a high level of public health protection across the EU.” 

The human medicines regulations 2012 will be updated over time to keep up with changes in practice and scientific advances.

The regulatory agency will keep the legislation and any subsequent amendments under review and consolidate the law again in future when it is appropriate to do so.

Olya Melnitchouk is an associate and Alison McAdams is a partner at DAC Beachcroft

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