Life Sciences Regulatory

Legal and regulatory frameworks are constantly evolving in the life sciences sector to keep up with innovative therapies, diagnostics and other medical technologies, as well as increasing services provision by manufacturers and other suppliers. In such a highly regulated and much scrutinised sector we understand you need a legal team who can proactively advise on your legal and regulatory risk.

CMS’ life sciences regulatory team

CMS’ life sciences regulatory team regularly handle business critical investigations for a wide variety of organisations including start-ups, universities, pharmaceutical, medical device and diagnostics companies, both in the UK and across multiple jurisdictions, for both MA holders and CE markers as well as for distribution entities. We are experienced in advising in connection with the various UK self-regulatory regimes for life science businesses in connection with promotional activity and of the associated expectations and obligations concerning transparency and proper disclosure required to deliver effective self-regulation and to maintain compliance. Clients may sometimes get tripped up by trying to respond to queries raised under the industry self-regulatory regimes in an overly technical or legalistic manner, which risks leading to additional failings or to further whistleblowing complaints from within the organisation. However, we recognise the importance of responding with full awareness of the potential regulatory implications of a response. We also assist clients in improving compliance and other internal controls when deficiencies or weaknesses are discovered, including as part of remedial steps following audits.

Many of our team are active participants in key industry bodies, including BIA, ABHI, ABPI and MedTech Europe. Through these memberships we help, amongst other things, to define the legal and compliance frameworks in which our clients operate. We also work closely with industry experts, including academics and scientists in regulatory specialisms as required, to provide you with commercial legal solutions to your industry-specific issues.

Our recent experience related to life sciences regulation includes:

• Various pharmaceutical manufacturers on alleged serious breaches of pharmaceutical regulatory and ABPI Code (i.e. industry self-regulatory) requirements in the UK and criminal law, including bribery of healthcare professionals, in some cases in combination with internal employment grievances. These investigations have frequently followed whistleblower or other complaints made directly to the PMCPA under the ABPI Code including in in some cases internal employment grievances or complaints about non-compliant conduct of individuals as well as other regulatory breaches.
• Various CROs and clinical trial sponsors on critical findings arising from GCP inspections and on subsequent responses and remediation programmes and also on reporting to inspection units at regulatory authorities.
• A pharmaceutical company regarding internal whistleblower allegations of unethical practices concerning the pre-launch marketing of a new drug product.
• A medical devices manufacturer on alleged breaches of post-market surveillance and vigilance reporting requirements leading to interview, prosecution and acquittal.
• An academic institution on governance issues and implications of non-compliances regarding manufacture and supply of investigational technologies for human use.

To find out more about other related services you can visit the Risk and Investigations expertise section.