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In the early years of the Scottish Parliament, petitions relating to accessing life saving, or prolonging, new treatments proved to be some of the most emotive, and effective it has had to listen to.

In the last session, Tina McGeever and her husband Mike Gray brought their moving appeal for equality of access to cancer treatments to Holyrood after terminal bowel cancer sufferer Gray was initially denied the life-prolonging drug Cetuximab by his health board, leaving them to find the funds for his treatment themselves. Gray passed away in 2008, however, their successful petition shone a light on inequalities in the system and led to new guidance being issued to all health boards two years later.

The guidance was intended to result in clearer and easier to follow policies for patients looking to access new medicines, as then Health Secretary Nicola Sturgeon explained:

“We already have a very fair, rigorous and quick system for appraising NHS drugs in Scotland. The Scottish Medicines Consortium (SMC) considers whether newly-licensed drugs should be used nationwide and recommends them for use where they are proved to be safe, clinically effective and cost-effective.

“Even where a medicine isn’t recommended by the SMC for general use, patients in Scotland can still get it on the NHS if their clinician believes it is appropriate and obtains permission from their local health board.

“But what was clear from the extensive work we have done with the Parliament’s Petitions Committee is that navigating the system is not always easy - particularly when patients and their loved ones are dealing with very difficult circumstances.”

The guidance was expected to change that by making it explicit to health boards what was expected of them. However, as the petitions system continues to highlight, challenges in accessing new medicines remain.

Recent petitions on medicines for rare diseases have reignited the debate about the process and, like McGeever’s, they are also provoking change.

One petition submitted on behalf of Rare Disease UK called for a review of the mechanism and methodology used by the SMC to appraise the value of medicines for orphan diseases – illnesses that affect fewer than 1 in 2,000 people – and to instruct the Chief Medical Officer to revise the criteria for Individual Patient Treatment Requests (IPTRs) – which allow for the clinical consideration of “not recommended” medicines for individual patients in certain circumstances. The petition was among those referred to the Health and Sport Committee, which agreed last year to hold its own inquiry. It began taking evidence in the autumn and since then it has held lively evidence sessions with witnesses including the SMC, the Association of the British Pharmaceutical Industry (ABPI), and the Royal College of Physicians, as well as a special session dedicated to accessing cancer drug treatments.

However, last November new Health Secretary Alex Neil announced that the Scottish Government would also hold its own review to look at “every aspect of the introduction of new medicines, from national advice to local decision-making, to establish whether any further improvements can be made.”

Committee convener, Duncan McNeil MSP initially expressed surprise that the Government had chosen to announce a separate inquiry given the committee’s ongoing work. However, he now believes that the evidence uncovered by the committee made it “necessary” for the Scottish Government to take a closer look at the issues that the committee had helped to bring into the open.

“My opinion is they were listening very carefully to the representations that were being made, the issues that were being raised, and I hope that that will result in a system that will be held in greater respect, that people will be able to access and understand, and it will have buy-in from the medical profession as being credible. Whereas, at this point there is a lot of confusion, misinformation and bureaucracy in the system,” he explains.

“In their evidence the clinicians were saying the outcomes are not good, to go through that process was very uncertain and, indeed, in their view, in many cases it wasn’t going to change the situation. So they were discouraged, they didn’t understand how the positive decisions were made. They didn’t understand why the refusals were made. So it needs to open up. People need to have a greater understanding about the system and how it applies and what likelihood there is of changing decisions.”

And it appears the Scottish Government has been paying attention, as early this year, the Health Secretary wrote to the committee to inform them that it will introduce, as a short-term measure, a £21m Orphan Drugs Fund to cover the cost of medicines for individual patients with rare conditions that are not available for treatment care of routine prescription.

“It is only right that Scottish patients with rare conditions have access to innovative medicines which are clinically justified and that they are not disadvantaged due to the very high cost of these treatments,” Neil said when he announced the fund in January, adding that the fund will “complement” the “globally respected” work of the SMC and bridge the period to the establishment of value based pricing for medicines in 2014.

McNeil says the announcement showed that the Government has been following the committee’s work closely.

“A government that is worth the name will be looking at that and moving with that and trying to get ahead of that evidence being presented and respond to it. But we could not have imagined such a significant response just a few months into that inquiry,” he admits.

However, he adds that this raises a question as to whether this reform would have been achieved without the public campaigns and the committee’s interest.

“Would we have got the fund that has been created? Would that be available now,” he asks.

“So that is the negative side of it. I take the view that if those people hadn’t petitioned the Parliament, if those people hadn’t been prepared to highlight and campaign on this issue then would we have reached this point?”

Following this early success, however, the committee’s inquiry is now on pause until the Scottish Government’s review has been published. When questioned, Neil told Holyrood that the Government will respond to the review after considering its recommendations, which will be submitted to ministers at the end of March. Once the review has been published, and the committee has had time to digest it, McNeil says it plans to hold another evidence session with the Health Secretary, review lead, Professor Philip Routledge, Professor Charles Swainson, who is examining the current IPTR arrangements as part of the review, and the Chief Pharmaceutical Officer, Professor Bill Scott, which McNeil says is likely to be in early May.

The committee then hopes to publish its own final report before the summer recess to allow it to move on to other things in the autumn.

“So we are all waiting with interest now to learn what the conclusions will be,” McNeil says.

“We’ve done part of the job but it is not finished yet.”

As it happens, this year is also the SMC’s 10th anniversary, which it marked with an event in Edinburgh last week. However, on the morn of the conference, Scottish Labour soured the celebrations with a blistering attack on the SMC’s “astounding” decision to hire a PR firm to help it address criticisms over the current system, particularly in light of the differences in availability between Scotland and England of some high-profile new medicines.

“There have been legitimate questions asked about how the SMC operates and how new drugs become available. These questions have been raised by doctors and patients. For this to be dismissed as people not understanding their work, or it being a presentational problem, shows just how out of touch the SMC has become, Scottish Labour’s shadow health secretary Jackie Baillie said.

“It just doesn’t seem right that the SMC hires their own spin doctors to seek endorsements in order to drown out the views of doctors and patients,” Baillie added, as she called on the SNP to put a stop to this “unacceptable use of public money”.

However, SMC chair, Professor Angela Timoney, says she welcomes the review and the opportunity it presents for the organisation to demonstrate its “strengths”.

“SMC recognises the importance of an effective and consistent approach to the introduction of new medicines in NHS Scotland. We welcome this opportunity to demonstrate our strengths and have participated fully in the review currently being undertaken by the Scottish Government, that has examined processes from the initial SMC assessment to local decision making, through the work of both Professor Philip Routledge and Professor Bill Scott,” Timoney tells Holyrood.

“We are pleased that the Cabinet Secretary, Mr Neil, has continued to acknowledge the international respect for SMC and the speed and rigour of our processes. The SMC process is renowned internationally, but we are always willing to improve how we evaluate new medicines. We have given Professor Routledge our full support in the part he has played in this review and we look forward to publication of the findings.”

However, Sandra Auld, Operations Director, ABPI Scotland, who also welcomes the review and inquiry, argues that the fact they are taking place is “an acceptance that there is a problem with the current system”.

And yet, another unavoidable aspect of this debate is the high cost of some of these new treatments. The Scottish Government points out that pharmaceutical companies are encouraged to off er a discount on medicines in Scotland through existing Patient Access Scheme arrangements and, in addition, it says the new UK system of value based pricing will influence the agreed price in the future. Furthermore, better prescribing, campaigns targeting drug wastage, and a fall in the cost of some drugs has led to some more general savings. But despite this, the drugs bill in Scotland for 2010-11 was in the region of £1.3bn, representing roughly 12 per cent of NHS board expenditure, with the total gross cost to NHSScotland of medicines projected to increase by between 3-4 per cent during 2011-15.

However, Auld insists that it is “a misconception that NHSScotland’s medicines bill is out of control and needs to be curbed”.

“In fact medicines spending in the UK is lower than in most other European countries,” she says.

“This is despite a rise in the volume of medicines being prescribed. Audit Scotland points out that the quantity has risen by 33 per cent in the years 2004/05 and 2011/12. In the same period, the real-terms spending on medicines has actually fallen by 11 per cent.”

Auld argues that it is also worth bearing in mind that “every single medicine accepted for use in Scotland by the SMC has proved that it is value for money, in a way that few other aspects of NHSScotland spending have to do.”

But she goes on to argue that the criteria used by the SMC to make these assessments needs to widen to take into account the wider societal benefits of new medicines, and adds that ABPI Scotland hopes the inquiry and review will recommend this.

She explains: “As the role of NHSScotland evolves towards long term and social care, so too should the way we assess the value of what the treatments administered by NHSScotland are actually achieving. For example, additional criteria such as whether a new treatment can make it easier to get a person back to work, or whether it reduces the need for hospital admissions, would go some way to improving access in Scotland.”

Auld also points out that there is another economic aspect to this debate.

“As Scotland strives to achieve its ambitious target of doubling the economic impact of the life sciences sector by 2020, we would question what message it sends to an industry at the cutting edge of medical research that even if they develop and trial their new treatments here, they might not be used.”

And while she says they welcome initiatives such as the recently announced Orphan Drugs Fund, she calls it a “short-term measure”.

“Like the cancer drugs fund in England, it is solving a symptom of the problem – lack of access to innovative new medicines for patients – but we believe it would be better for patients if we fixed the underlying problem, which is the way we assess the impact of a new medicine on wider society.”

Despite this, Scottish Conservative health spokesman, Jackson Carlaw, continues to believe that the Scottish version of the cancer drugs fund is necessary if Scotland is to avoid being left behind when it comes to treating patients with advanced and terminal cancer.

“Whatever its name, a fund that allows access to cancer drugs not routinely available on the NHS is absolutely vital,” he argues.

“The SNP has denied this, and its orphan drugs fund – while welcome – will not address a wide range of common cancers.”

In response, Neil counters that: “The benefits of creating a Scottish Cancer Drugs Fund have been debated in the Scottish Parliament twice and on both occasions Parliament agreed to continue improving access to clinically and cost-effective medicines throughout all parts of Scotland.”

However, Carlaw persists that the current arrangements potentially deny NHS patients in Scotland access to some life-enhancing and life-extending drugs that are available to NHS patients in England and questions the SNP Government’s funding priorities.

“If it has £20 million for that [Orphan Drugs Fund] and can afford free prescriptions for even Scotland’s wealthiest individuals, it can find the cash for a cancer drugs fund,” he states.

However, as the row rumbles on, Ian Welsh, chief executive, the ALLIANCE urges those involved to remember the people behind the prescriptions.

“Having good access to new medicines can be vitally important,” he says.

“For people who have long-term conditions, timely access can make a real difference to their lives. Enabling people to stay as well as possible for as long as possible can help them remain independent, active and able to contribute to society, families and communities.”

The current debate about accessing medicines is a timely one as next month will mark the second anniversary of the introduction of free prescriptions in Scotland. The abolition of prescription charges for all people with longterm conditions was one of the issues that led to the creation of the ALLIANCE, Welsh recalls, and so, unsurprisingly, it is a policy that the organisation “strongly supports”.

“Many people who live with long-term conditions live either in poverty or close to the poverty line. As a result, prior to the abolition of prescription charges, many have been forced to make difficult decisions between medication and other vital everyday items. In a recent survey, we heard from some members of times when they have foregone or delayed collecting prescriptions because they could not afford them,” he says.

“People not collecting prescribed medicines can have detrimental and long-term effects. Access to medicines, at no charge, is vital to support people in self-managing their condition, something that is essential to individual quality of life as well as to reducing complications or hospital admissions.”

The ALLIANCE has been holding a series of joint seminars with the ABPI on areas of cross interest, and Welsh says that during a recent event focused on value based pricing, much of the discussion centered on access to new medicines.

Looking ahead, he says the ALLIANCE would like to see the development of a long-term conditions research network, which would provide an infrastructure for easier referral of people who live with long-term conditions to clinical trials, and they would also like to see the Quality Adjusted Life Year (QALY) process, which takes into account how a medicine affects both a patient’s quantity and quality of life, enhanced with the consideration of social elements.

However, for now, he welcomes the renewed focus on the process for accessing new medicines as he says, their members, like those who have petitioned the Parliament, have been expressing concern that the current process is “too complex and lacks transparency”.

“The process is too geared towards health professionals rather than the wider public and it is often too difficult for people who do not have a clinical background to engage in,” he says.

“Many of our member organisations have highlighted the lengthy process to submit information to a system which, ultimately, they did not feel gave sufficient consideration to their views.

“As a result, some of our members have expressed concern that the views of people who live with long-term conditions are not being considered.”

Clearer information is “vital”, he says, and argues that making this information available to ‘lay people’ would allow patients and their representatives to engage more effectively with the process, to everyone’s benefit.

“Drawing input from the public in decisions about access to new medicines and setting priorities is a vital part of the process, ensuring accountability and a wider understanding of the process. The system needs a revamp in order to tackle these issues.”