Drug Industry Needs to Adapt Regulatory Procedures
In light of a string of recent instances, where weaknesses in the regulation of pharmaceutical products have been highlighted, the drug industry now faces increasing pressure to adapt, or instead be monitored by external sources. Concerns have been raised by pharmaceutical firms and patients alike - all connected with the procedures implemented by the Prescription Medicine Code of Practice Authority. In 2006, the code was strengthened in tone. Consequently, a number of well publicised investigations have taken place, amid fears that these lack depth, and that the companies themselves could be legally tarnished.
One person to comment on the situation is Marc Dalby, who works as a Consultant at law group Lovells, and was previously the Legal Director at the UK division of US Pharmas firm MSD. Mr Dalby suggested that one possible route to take in the future would involve a strategy focusing more on inquisition. In this way, he added, staff at the PCMPA would take the role of prosecutors and obtain relevant and complete information from all parties concerned, which would then be submitted to an independent judicial panel.
A criticism frequently thrown at the PMCPA is that, in instances when media coverage highlights how drugs companies have committed breaches of ethical practice, officials there discuss the claims with the companies implicated, but do not refer back to those affected by the action. A further point of contest is that journalists are often reluctant to provide additional information to assist the consequent investigations.
Since last year, when the PMCPA's code of practice was modified, the number of complaints originating from media coverage has increased significantly. One example of this took place pretty recently, and involved the Guardian newspaper. It detailed the case of one Lisa Jardine. Ms Jardine, who, at London's Queen Mary College, works as a Professor of Renaissance Studies, was allegedly bribed by Roche to publicise Herceptin, a drug designed for patients with breast cancer. Instead of obtaining the professor's story, the PMCPA conceded that Roche's sequence of events was the truth.
Elsewhere, other investigations have proved how the defences of both journalists, and the subjects of their reports, crumble against the power of counter-claims offered by self-defending pharmaceutical firms. Despite this, such pharmaceutical companies have themselves complained at the level of scrutiny exercised, some claiming that their PMCPA defence could see them exposed, should the likes of the medicines regulator within UK government opt for prosecution.
Certain figures have urged for the PMCPA to reinforce its regulatory powers with fines. Currently, the body is restricted to admonishing firms in public or, ultimately, recommending that the firm is suspended from the Association of the British Pharmaceutical Industry.
The PMCPA's head, Heather Simmonds, emphasised how firms considered her investigations to be extremely serious, and reaffirmed how each and every decision made had a "balance of probabilities" as its basis, involving staff that underwent scrutiny from an appeal body, which comprised of lay members, and with a QC at its head. She added that a judicial review may also come into play.
According to the UK head of French pharmas firm Sanofi-Aventis, Nigel Brooksby, who additionally is the Association of the British Pharmaceutical Industry's President, a review of the PMCPA has commenced. He added that contemplation would be given regarding whether the body's investigative procedures required reinforcement.
As per Lovell's Mr Dalby: "The problem is not the code of practice, which is probably the most advanced in the world. The challenge is to continue providing visible administration and enforcement, which are really key areas for credibility. The industry must keep convincing its stakeholders that it recognises the importance of self-regulation."
Source - Pharmaceutical International's Editor
