As well as the recommendations - which range from requiring organisations engaging in clinical trial work with the NHS to publish the results, to developing further guidelines on industry's relationships with patient groups - the ABPI document also responds to some of the issues raised at the inquiry.
The ABPI document was submitted to the committee in advance of the oral evidence session being held on Thursday, January 13, at which the ABPI will be represented by Vincent Lawton, President of the ABPI, and Dr Richard Barker, Director General.
The recommendations have been made against a background of ABPI support for and commitment to more openness across the whole of the healthcare system.
The ABPI's recommendations cover a number of areas, including:
Clinical trials. There is now international agreement that details of pharmaceutical industry-sponsored trials will be publicly registered from their inception, and that summary results of such trials will also be published. The ABPI recommends to the committee that all trials involving the NHS should include a requirement to publish as part of the contract.
Product safety monitoring. Doctors in the acute sector should be regularly assessed on their use of the current Yellow Card reporting system, and direct patient reporting of adverse drug reactions should be more aggressively promoted. The MHRA should receive more funds for increased monitoring, and should regularly publish Yellow Card data.
Ensuring patient interests are represented. Further guidelines on relationships between the pharmaceutical industry and patient groups should be developed.
Ensuring appropriate prescribing of medicines. Both the National Institute for Clinical Excellence and the Healthcare Commission should ensure that NICE guidance is implemented by monitoring the impact on doctors' prescribing.
Better information for patients. The MHRA should introduce user testing of patient information leaflets about medicines to increase their usefulness to patients, and pharmaceutical companies should be encouraged to make scientifically reliable information available to the public.
The pharmaceutical industry is already extremely highly regulated and committed to the highest standards of ethical and business conduct. But we recognise that an issue of trust has arisen, and greater trust needs to be built on increased transparency," said Dr Barker.
We believe these recommendations are practicable and that they go a long way towards addressing this issue."
The ABPI document also examines several areas which were identified by witnesses to the inquiry, including:
'Disease mongering'. Diseases are classified by a rigorous process independent of industry. Preventative care - such as the treatment of osteoporosis, high blood pressure and high cholesterol, that were criticised as "disease mongering" - is fully in line with NHS strategy.
'Ghost writers'. As in many other contexts, it is common practice for specialist medical writers to raise the quality of publications through their skills in language and communications, expertise in presenting data, understanding of publication guidelines and convention, and/or time. But the industry does not support the presentation of reports that do not reflect the considered views of the stated authors. No serious investigator would risk their reputation by simply adding their name to a paper.
Links with patient groups. Industry works openly with patient groups to raise awareness of medical conditions and to improve healthcare delivery. The funding of such groups is transparent, with patients groups retaining absolute freedom to accept or decline funding.
Relationships with doctors. The ABPI's Code of Practice requires that gifts to healthcare professionals must be relevant to their work and never above the value of £6, and that hospitality must be secondary to the purpose of any meeting and not out of proportion. A review of the ABPI code is currently being undertaken, and the ABPI is canvassing opinion on this widely.
Are all new medicines genuine innovation? A new medicine is not licensed unless it can be proved to be at least as effective as existing treatments. A particular medicine may be more suited to a person's genetic make-up than another, both in terms of effectiveness and/or side-effects.
For further information, please contact: ABPI Press Office 020 7747 1410