The Regulatory Enforcement and Sanctions Act 2008 (RESA) came into force on 22 July 2008 . This could have significant regulatory compliance implications for lifescience companies or individuals operating in the UK in the medicines, medical devices and diagnostics sectors and also for human tissue establishments.

Companies / affected persons should carefully consider the implications of RESA powers being introduced in their sector and be ready to participate in the consultation process, which is required before any RESA power(s) can be conferred upon a regulator, either by taking part directly in the consultation or participating via representative organisations like trade associations or professional bodies.

RESA creates provision for new civil sanctions to be imposed as an alternative to prosecution for the enforcement of existing criminal offences arising under specified lifesciences regulations, such as the Medicines Act 1968 or the Consumer Protection Act 1987 (under which the devices and diagnostics legislation is enforced) or offences which fall within the remit of designated regulators like the Human Tissue Authority (HTA). The key objective of RESA is to allow regulators to respond to cases of non-compliance in a more flexible, effective and proportionate manner. RESA requires regulators granted the new powers under the Act to prepare and publish guidance about how the sanction(s) will be used and about how the offence to which the power in question relates is enforced. They will also be required to act in accordance with principles of transparency, accountability, proportionality and consistency and to target only cases in which action is needed.

The new civil sanctions could include powers to:

  • impose fixed or variable monetary penalties;

  • issue stop notices (similar to "cease and desist" orders);

  • accept enforcement undertakings from companies; and

  • impose other discretionary requirements, which could include provision for payment of the regulator's costs of investigation, administration and obtaining legal and/or expert advice in relation to imposing a discretionary requirement.

Though RESA creates additional new potential civil liability exposure for lifesciences companies, double jeopardy would be avoided as the discharge of the civil sanction liability by the person / company in question would mean that they could not at any future date be prosecuted for the offence in question.

If Ministers choose to act to exercise their powers under RESA in relation to UK lifescience legislation RESA could supplement the current enforcement powers of the MHRA (the UK competent authority for medicines and medical devices) and the HTA, amongst other UK regulators, with a range of alternative civil sanctions. These new civil sanctions would allow the MHRA and the HTA to tackle non-compliance by way of civil rather than criminal sanctions in cases where the regulator is satisfied that the person / company in question would be liable to be convicted (or, in the case of "stop notices" where the regulator reasonably believes an activity presenting a serious risk of causing serious harm to human health, amongst other matters, is likely to be carried on by the person / company and is likely to involve the committing of a relevant offence).

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 11/08/2008.