The Scottish Medicines Consortium (SMC) should hold its meetings in public, and invite companies whose drugs are being examined to give evidence at its main appraisal meetings, says an independent review.
Holding its meetings in public would allow patients and patient group representatives to see how their submissions have contributed to the drug's evaluation by the SMC, and enable people working in the NHS and the pharmaceutical industry to observe the "rigour of the scrutiny" being applied to the sources of evidence, the report proposes.The reports of the review also call for: - more public involvement within the SMC, with the Consortium being "encouraged" to set up a new body such as a citizens' council or jury; - increased flexibility in the consideration of new evidence on cost or effectiveness of a drug while it is being addressed, enabling the process to be paused for further discussion with the manufacturer; - and more public involvement in NHS Board Area Drug and Therapeutic Committee (ADTC) and Individual Patient Treatment Request (IPTR) processes. National data on NHS Board decisions on IPTRs should be published, making them more transparent, and there should be increased scrutiny and standards put in place in relation to requests for drugs not recommended for routine use.
The government said that its response to the review, alongside any recommendations from the forthcoming Health and Sport Committee report into new medicines, will be open for a brief consultation this summer.
"Many of the recommendations focus around making sure the system is as open and transparent as possible, and I want everyone to have their say on how we make sure that Scotland has the best system possible," said Health Secretary Alex Neil.
"I am proud that Scotland is among the fastest and most efficient medicine review processes anywhere in the world. However, we can't overlook the concerns raised by clinicians, charities and patients about access to medicines," he said, adding that this was why he commissioned this independent review.
The work was conducted by Professor Philip Routledge, professor of clinical pharmacology at Cardiff University, who reviewed the SMC's current new medicines assessment processes against those of similar organisations elsewhere, to see if there are any areas of good practice that Scotland could learn from.
Scotland's chief pharmaceutical officer, Professor Bill Scott, also commissioned Professor Charles Swainson, former medical director at NHS Lothian, to review how SMC decisions are implemented by ADTCs, to ensure that there is "a consistent and effective approach" - including IPTRs - to establish whether any further improvements can be made.
Scottish Labour health spokeswoman Jackie Baillie welcomed the review's recommendations for greater transparency in the decision-making process over access to new drugs, and the consideration of a citizens' jury, but added that Labour's greatest concerns remain around the numerous different decision-making bodies."Scotland simply does not need more than a dozen different boards deciding upon which medicines should be available for use. It does not make sense, and nor is it fair, that someone in Stirling can get access to a medicine which someone in Stornoway can't. That fundamental problem remains," she said.
Scottish Liberal Democrat Jim Hume said the review's finding that a quarter of SMC-recommended medicines do not make health boards' prescribing lists was "troubling."
"This needs to be tackled, as does the process for applying for new drugs which aren't available on the NHS. It cannot be the case that those who shout the loudest or know the most about the system are most likely to gain," said Mr Hume.
Mr Neil also pointed out that an interim recommendation of the review - for a £21 million fund to cover the costs of medicines for patients with very rare conditions - was introduced in January, and that the latest figures show that 71 patients in Scotland have received - or are about to receive - Vertex Pharmaceuticals' Kalydeco (ivacaftor), used to treat a rare form of cystic fibrosis. This total includes 24 children aged between six and 16.
The fund was announced following interim advice from Prof Swainson that it would be justified, while Prof Routledge also recommended that the SMC should establish a policy specifically related to these medicines.
The Scottish Parliament's Health and Sport Committee is due to hold an evidence session on May 7 with Profs Routledge, Scott and Swainson and Mr Neil on the findings of the review. The panel has been examining general issues regarding the approval process for newly-licensed medicines and the IPTR system, and has, said Committee convener Duncan McNeil, heard that patients face many issues in accessing new medicines - "from funding for new drugs to the difficult process patients have to go through to access drugs that haven't been approved."The Committee will hold an evidence session for patients, clinicians and the industry at the end of this month.
- At the weekend, it was reported that 39% of oncologists and haematologists in Scotland surveyed said they were aware of cancer patients who have relocated to England to receive treatment. Also, there are 34 drugs which are not recommended by the SMC which the clinicians say they would like to have access to, "in a perfect world," according to the survey, which was commissioned by Roche Products Ltd.