Nearly 50% of those who sit on or advise the Scottish Medicines Consortium have interests in drugs companies, sparking concerns the SMC is compromised.
The NHS in Scotland spends around £1.4 billion a year on drugs for patients - a big chunk of its budget. Around £1bn of this sum is spent in general practice, while NHS boards use around 10% of their funds on prescription drugs. The NHS across the UK is hugely lucrative for "big pharma", which provides the vital medicines.
The SMC, which has a £1.5 million taxpayer-funded budget, is the gatekeeper body that makes recommendations to NHS boards on newly licensed medicines. It consists of the SMC itself, its New Drugs Committee (NDC), and a large pool of advisers.
The NDC makes an initial assessment, after which the SMC issues a judgment. The SMC, comprising clinicians, lay members and members of the Association of the British Pharmaceutical Industry (ABPI), does not produce an annual report and meets in private.
The Sunday Herald can now reveal the extensive links between SMC figures and an industry that has a huge commercial interest in the decisions it makes.
Members of the consortium, the NDC, and the clinical advisers have to provide a declaration of interest revealing links to pharmaceutical companies.
These are "personal" interests, including consultancies, fees, shares and hospitality, or "non-personal" items, such as grants or fellowships that benefit an individual's department.
The interests have to be declared annually to the SMC and at meetings. The Scottish Government ratifies new members to the SMC.
Of the 21 members of the NDC in 2013, around 48% declared some form of interest in the pharmaceutical industry.
Dr Alan MacDonald, the chair of the committee and a consultant rheumatologist at NHS Grampian, declared a "speaker fee" from pharma giant, Pfizer. A spokesman for NHS Grampian said MacDonald received the payment in May 2012, so this interest would have lapsed by the time he became vice-chair and then chair of the committee.
Similarly, 12 of the 35 members of the full consortium declared in 2013 either personal or non-personal links to the industry - around 35% of the total.
The clinical experts who advise the SMC have also registered links to big pharma.
Of the near 600 experts - mostly consultants - well over 200 have declared interests in the industry. These include shareholdings, cash for commercial studies, research grants, an honorarium for lectures, advisory board fees, funding to attend meetings and travel costs.
Of the three bodies where declarations must be made, around 45% have declared an interest in the pharma industry.
There is no suggestion of wrongdoing by any of the individuals, or that interests have not been properly declared at meetings. The SMC also has rules on when its members should be excluded from discussions in the event of a conflict of interest.
However, the revelations have triggered a debate on whether the SMC is sufficiently independent.
David Miller, a sociology professor at Bath University, said: "Regulatory bodies should work to minimise or eliminate conflict of interest. In the case of the SMC, it has not been transparent. This shows the need for much more stringent rules on conflict of interest, as well as effective means of monitoring and enforcing them."
Neil Findlay, Scottish Labour's health spokesman, said: "The pharmaceutical industry is worth over £1bn in Scotland, so it's imperative that those making decisions on which new drugs come on to the market are doing so based on the needs of patients and their expertise in the field. Commercial interests cannot be a factor in making such important decisions, which is why the system must be fully transparent."
Miller added: "Professional bodies such as the General Medical Council should investigate the apparently widespread conflicts of interest of doctors advising the SMC."
In 2012, SNP Health Secretary Alex Neil ordered a review of the SMC and its assessment processes for new medicines.
Patients and charities had expressed concern about some drugs not being made available. The review backed reforms to make the body more transparent, including holding meetings in public, which the SMC intends to do.
A spokesperson for the British Medical Association in Scotland said the BMA backed a registration system for all health professionals, adding: "Financial relationships between industry and healthcare professionals have the potential to represent, or be seen to represent, unacceptable and unethical conflicts of interest. The BMA supports in principle the proposal to introduce a register which details payments made by industry and commerce to healthcare professionals."
A spokesperson for the SMC said: "NHS Scotland takes prides in the fact that its clinicians are at the forefront of clinical research. In order to engage in research about a medicine while in development and before it receives a licence, clinicians must work with the pharmaceutical company that is developing the medicine.
"The fact that many of our members have experience of clinical research makes them an asset to SMC - it means they are in a strong position to critique submissions from manufacturers and they are also well placed to understand the very complicated information and analysis that our members are regularly asked to comment upon."