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Scottish drug approval process to be revamped

World News | October 09, 2013


Lynne Taylor

Scottish drug approval process to be revamped

Scottish Health Secretary Alex Neil has announced a package of measures aimed at making Scotland’s drug approval system more transparent and increasing access to medicines for end-of-life care and very rare conditions.

For evaluation of such treatments, the Scottish Medicines Consortium (SMC) has been directed to conclude, by year-end, a review to establish different and more flexible approaches, which will increase access to these medicines for Scottish patients. The government says the new approach will be implemented early in 2014.
 
Other measures announced by Mr Neil include:
- extension of the £20 million Rare Conditions Medicines Fund to 2016. The Fund was set up in January this year to cover orphan drugs used to treat conditions for which there are no more than 2,000 patients;
- improved patient support for engaging in the drug approval process:
- additional investment of £1 million to support SMC in making its work more transparent:
- creation of a new peer approval system, led by local consultants, to allow clinicians to prescribe medicines that are not accepted for routine use by the SMC – replacing Individual Patient Treatment Requests (IPTRs); and
- an opportunity for the SMC to appraise new medicines which have not yet been submitted by manufacturers where these are considered clinically important to NHS Scotland.
 
The measures represent a first step in a wider process to determine a Scottish model of value-based medicines assessment, and follows a report issued in July by the Parliamentary Health Committee which said that further changes were needed to create a better and more transparent system for access new medicines.
 
The Committee also called on the government to address issues around IPTR, area drug and therapeutic committees, clinical trials and value-based pricing.
 
The new measures have been welcomed by patient advocates including Myeloma UK chief executive Eric Low, who also pointed that that “it is critically important that while improvements to access to medicines are made we also ensure that we are getting genuine value for money, and that the pharmaceutical industry improves the type and quality of information it provides to get their medicines funded on the NHS.”
 
“I strongly believe that the SMC are best-placed to help make this happen,” said Mr Low.
SMC chair Professor Angela Timoney responded that the Consortium “fully supports patient access to clinically-effective new medicines at a price that is fair for all.”

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