Regulatory Focus™ > News Articles > Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

Posted 12 January 2012 | By Alexander Gaffney, RAC 

United Kingdom Health Secretary Andrew Lansley announced a new initiative aimed at "ensuring the safety of people seeking cosmetic interventions" on 11 January in response to the recent Poly Implant Prothese (PIP) breast implant crisis.

Lansley announced that an expert review group led by National Health Service (NHS) Medical Director Professor Sir Bruce Keough will look at how NHS can better collect quality data on their devices, whether cosmetic products and interventions are "appropriately regulated", and how UK and European regulations can be updated.

The move mirrors one made last week by top French regulatory officials and European Medicines Agency (EMA) Executive Director Guido Rasi, all of whom called for reformed medical device regulations to prevent future regulatory scandals and patient harm.

"Lessons also need to be learned from how the regulation of medical devices operates at a European level," said Lansley's press statement, adding that "this work is already underway."

The Keough investigation will look to influence the European Commission, which is investigating the scandal.

"I'm concerned that the sector as a whole does not have the systems for monitoring the results for patients and alerting us to possible problems," said Keough. "I will work with the industry to improve regulation and governance and increase consumer confidence."

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