New Civil Sanctions For Lifesciences Companies Operating In The UK

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...

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