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UK considers greater self-regulation of pharmacies

And MHRA to review sanctions and penalties

Greater self-regulation may be introduced to manage the sale and supply of medicines in registered pharmacies in the UK to more appropriately manage support for public safety.

The Department of Health's (DH) chief pharmaceutical officers issued a statement saying they are in the early stages of exploratory work analysing the role of both centralised medicines legislation, such as the Medicines and Healthcare products Regulatory Agency (MHRA), and independent professional regulation, such as standards provided by the General Pharmaceutical Council (GPhC).

Central to the officers' work is the balance between the two forms of regulation, and their statement said that 'now is the time to consider the interplay' between the two in the context of government initiatives to move towards self-regulation ahead of legislation, except in instances where this is unavoidable.

The DH is now in early discussions with the MHRA and professional bodies to explore the scope of both regulation and legislation, and to reduce obstacles to the responsible development of practice and innovation within UK pharmacies.

This move towards self-regulation was also mentioned by the MHRA in a statement concerning its separate but linked review of its sanctions and penalties.

The review, which covers the Agency's sanctions and penalties related to medicines, devices, the supply of blood and Good Laboratory Practice, will also take into account the government's wider aims to avoid using detailed legislation.

Suggestions for amendments to the MHRA's current methods include the introduction of civil sanctions to replace certain criminal sanctions, and whether these sanctions can be managed through a self-regulation system.

In addition, the MHRA will explore whether existing offences and penalties are 'necessary, proportionate and accompanied by the right penalties', in addition to the possible introduction of new offences to ensure the protection of public health.

The MHRA will be developing the timetable for the sanctions and penalties review over the next few months, taking into account the wider reforms being explored by the DH.

“The link of [DH's] work with a sanction and penalties review is significant, as it will influence analysis of the appropriateness and proportionality of existing offences,” said the MHRA.

31st October 2012

From: Regulatory, Healthcare



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