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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