Health Secretary Nicola Sturgeon
Statement in Scottish Parliament
Wednesday, March 25, 2009
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Parliament has already debated the findings of the Petitions Committee inquiry into the availability of cancer drugs in Scotland. I undertook at that time to take forward all of its recommendation.
Today I want to update members on our progress to improve the arrangements for introducing new medicines into the NHS in Scotland.
Drug expenditure in Scotland totals £1.22 billion a year. That is a very significant resource - almost 10 per cent of the NHS budget.
Our objective must be to ensure that this investment supports equitable access to new and innovative medicines on the NHS and that every pound derives the most benefit for patients.
Of course, tough decisions will always need to be made.
We must therefore make sure that our decision making processes are robust and that they achieve fairness and a consistency of approach; and that patients, carers and the public have a better understanding of how and why decisions are made.
Scotland is already well served by good, internationally regarded arrangements for the introduction of new medicines through the Scottish Medicines Consortium and NHS Quality Improvement Scotland.
The Scottish Medicines Consortium has done much to ensure evidence based recommendations for Scotland are made quickly for every new medicine following its launch.
And, we should applaud Scotland's prominent position in life sciences developments.
But we all want to make sure that more people in Scotland benefit from innovation.
I am therefore today announcing a series of developments that are designed to improve access to medicines on the NHS.
The first of these relates to exceptional prescribing arrangements.
Where a medicine is recommended by the Scottish Medicines Consortium, NHS boards should make it (or its equivalent) available where appropriate. Let me be clear patients should not have to rely on exceptional prescribing arrangements for medicines that are SMC recommended.
However, where a drug is not recommended, it is important that such arrangements are in place to consider the circumstances of individual patients which could nevertheless justify the medicine being prescribed.
Concerns have been expressed - most recently by the Rarer Cancers Forum - about the lack of consistency in exceptional prescribing arrangements between different NHS Boards.
Following the report from the Public Petitions Committee, the Scottish Government wrote to NHS Boards providing information on the end to end process for the introduction of new medicines; and the support arrangements and information that should be provided for patients. In addition NHS Boards were provided with a framework of principles, including specific principles for exceptional prescribing, to inform decision making at NHS Board level.
NHS Boards have responded positively and the outcome of the responses received will now be used as the basis for new guidance to be issued to Boards. The new guidance will also provide the basis for more effective monitoring of the arrangements across the NHS in Scotland.
I can also confirm that the Scottish Government has commissioned Health Rights Information Scotland to produce better information for the public on these arrangements.
The second development I am announcing today relates to greater transparency in the flexibility which can be used by the SMC in reaching decisions.
I can confirm today that the Scottish Medicines Consortium will shortly publish a set of modifiers which can be applied when considering new medicines.
The effect of these will be to ensure that, after the scientific, clinical and health economics evaluation of a new medicine, the full SMC can then consider if there are any special factors which should be taken into account. That allows greater flexibility to be exercised where there are potential clinical benefits of a drug but the standard methodology would not result in it being approved - for example, where it could deliver improvement in life expectancy, where it could deliver substantial improvement in quality of life without necessarily improving life expectancy or where there are no other therapeutic options.
The SMC will also retain the flexibility to look at any other special issues which may have been highlighted by the manufacturer of the medicine, by clinical experts or by patient interest groups. Let me underline that this flexibility can be applied to any new drug coming before the SMC, not just cancer medicines and not just end of life medicines.
The third development I want to update members on today relates to patient access schemes - sometimes referred to as market access or risk-sharing schemes which allow drugs companies to offer discounts or rebates that reduce the cost of a drug to the NHS.
Members will be aware of the Pharmaceutical Price Regulation Scheme (PPRS) - a voluntary agreement between the UK Health Departments and the Association of the British Pharmaceutical Industry (ABPI) designed to secure medicines at prices that are reasonable for the NHS but that also provide incentives for the pharmaceutical industry to develop new medicines.
Amongst a range of developments, the new PPRS agreement paves the way for a more systematic use of patient access schemes.
I therefore asked the SMC - through a short life working group - to advise me on the feasibility of patient access schemes in Scotland.
The short life working group has now reported back to me with the conclusion that such schemes could deliver benefits to patients in Scotland as a means of improving the cost-effectiveness of new medicines and facilitating access to products that might not otherwise secure SMC approval.
I can therefore announce today that I am accepting the recommendation of the SMC that a national framework for assessing proposed patient access schemes should be established. A single national framework will avoid duplication and the potential for different schemes to operate in different parts of the country.
These new arrangements, the operational details of which will now be finalised, will maintain the integrity of the current SMC arrangements and will operate independently of Scottish Ministers.
All of the developments that I have announced today will - individually and collectively - improve patients' access to medicines on the NHS.
They will be underpinned by work at national level to develop new IT and data analysis systems to support decision making and, crucially, provide information on medicines uptake and how medicines are being used.
Arrangements are in place to ensure better networking for those involved in planning and implementing the introduction of new medicines across Scotland in order to share learning and good practice from across the country.
And the academic sector is involved in taking forward the research agenda for health economics methodology, and the ethics of making difficult decisions.
Presiding Officer,
All of what I have announced today is about improving access to drugs on the NHS.
My objective is to ensure that we have a system in place that is, from end to end, robust, fair and well understood.
Such a system should ensure that where a patient could derive demonstrable benefit from a drug, it should be available on the NHS - either through SMC approval or exceptional prescribing. Conversely, where a drug is not so available, it should be because it would not deliver sufficient benefit and not for any other reason.
However, we must accept that even in these circumstances, some patients will wish to exercise their right to privately access a drug not available on the NHS.
In these circumstances, it is important to provide clarity to patients about the implications of such decisions for the NHS care they would otherwise be entitled to.
Therefore I am today - after consultation - publishing the final revised guidance on "co-payments" - those situations where NHS patients may wish to include elements of private healthcare, including medicines, in the management of their clinical conditions.
Members will know that this has proved to be a controversial and thorny issue.
However, I believe that as a result of working with key stakeholders the revised guidance provides greater clarity for NHS Boards, clinicians and patients.
The guidance is grounded in the fundamental principles of the NHS: namely that NHS treatment must be based on clinical need, not the ability to pay; that NHS care is free at the point of access; that patients can't pay the NHS to top up their care; and that the NHS must not in any way subsidise private treatment.
However, it also recognises that where a patient chooses to pay for part of their care privately then so long as questions of patient safety, clinical governance, probity and accountability can be answered, they should not necessarily lose out on the NHS care they would otherwise have been entitled to.
I believe the revised guidance, issued by the Chief Medical Officer, provides a framework within which the circumstances of individual patients can be fully considered. However, such arrangements will be the exception, not the norm.
I remain absolutely committed to ensuring the people of Scotland get the best care possible. I believe that by fully addressing the Petitions Committee's recommendations, and indeed going beyond them, the progress and series of measures I have described today will improve access to new medicines in the NHS in Scotland.