UK pharma in need of a check-up
SummaryThe government's Health Select Committee has published a stinging attack on the UK pharmaceutical industry. In a report spanning 126 pages and consisting of 48 conclusions and recommendations, the committee has lambasted the way in which the UK pharmaceutical industry conducts its business and the motives by which it is driven. Datamonitor's Duncan Emerton looks at the details...
Despite recognizing that the industry has improved the quality of life of many people and reduced the length of time spent in hospital, the Health Select Committee says that the industry has become dominated by marketing rather than science.
In its report, released last week, all aspects of the drug development and commercialization process in the come under fire. Most criticism is directed at questionable industry practices and procedures, and the failures within the Medicines and Healthcare Products Regulatory Agency (MHRA), the regulator. Recent scandals such as the problems surrounding the COX-2 inhibitor class of painkilling drugs and selective serotonin reuptake inhibitors for depression have served to highlight these problems, prompting the committee to call for radical review of procedures at the MHRA and a review of how pharmaceutical companies develop, market and sell their products to the medical community.
With regard to the development of medicines, the committee's main recommendation was for the introduction of an independently led clinical trials register. As part of the marketing approval process, all companies would need to add clinical trial data to this register to increase transparency and reassure all stakeholders that negative clinical trial data was not being sequestered. Some pharmaceutical companies, such as GlaxoSmithKline (GSK), already provide access to clinical trial data on their websites. However, making this a condition of marketing approval could potentially increase development times, and thus development costs, as companies go to extra lengths to ensure that the data is beyond reproach.
As for how medicines are marketed, the MPs believe that certain marketing practices encourage inappropriate prescribing and must be curbed, recommending that limits be set regarding the quantity of material prescribers receive, particularly in the first six months after launch. With a strong belief that less experienced medical staff are ill-equipped to cope effectively with the promotional tactics employed by the industry, stricter controls are needed, particularly to protect junior doctors, nurses and pharmacists with new prescribing powers.
In addition, the committee calls for illegal marketing practices to be reported directly to the MHRA, and for the MHRA to increase the effectiveness of its working relationship with the Prescription Medicines Code of Practice Authority, a committee that enforces the rules and regulations regarding medicines promotion in the UK. A comprehensive review of all procedures used to investigate complaints about breaches of these regulations is urgently required, so that they can be speeded up and rigorously enforced. Equally, the sanctions employed must be sufficiently potent that companies will think twice before attempting to use promotional procedures that could be deemed misleading.
Resistant to change
The government experts go on to recommend that all the promotional material for a new product be pre-vetted by the MHRA prior to publication, and that consideration be given to limiting the prescription of drugs less than two years old to more senior healthcare professionals. These measures are similar to practices employed by the Japanese government.
Wider prescribing rights would be permitted once comparative studies and trials investigating the potential adverse effects of the medicine in large populations had been undertaken, and after formal evaluation of the product in clinical practice by the Licensing Authority and/or the National Institute for Clinical Excellence. However, as drug pricing comes under the spotlight in most EU countries, including the , reducing the number of prescribers would ultimately lead to an increase in drug prices as companies seek a return on their investment.
Despite these recommendations, Lord Warner, the health minister and one of the sternest critics of the pharmaceutical industry, said in a statement after the publication of the report that "the government has an effective and proper working relationship with the pharmaceutical industry". However, Sir Richard Sykes, former chairman of GlaxoSmithKline said "the [pharmaceutical] industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in and that we should be supporting. I think there have to be some big changes."
Big changes maybe required, but as pricing pressures and R&D productivity continue to dog the one time darling of the economy, the pharmaceutical industry - while receptive to recommendations about how it conducts its business - will be resistant to significant change if it believes this will affect profits and sales growth in the future.