Scottish drug approval process to become more transparent
Scottish patients will benefit from an increased range of new medicines due to changes announced by Alex Neil, the Scottish health secretary.
The package of measures will ensure Scotland’s drug approval system becomes more transparent and increases access to medicines for end-of-life care and treating very rare conditions.
Neil has directed the Scottish Medicines Consortium (SMC), the body that approves medicines for use in the NHS in Scotland, to apply different, more flexible, approaches in the evaluation of medicines for end-of-life care and treating very rare conditions.
Additional improvements include:
- An extension of the $31.9 million Rare Medicines Drug Fund to 2016
- improved patient support for engaging in the medicines approval process
- additional investment of $1.6 million to support SMC to make its work more transparent
- the creation of a new peer approval system to allow clinicians to prescribe medicines not accepted for routine use by the SMC, replacing Individual Patient Treatment Requests (IPTRs)
- the opportunity for the SMC to appraise new medicines not yet submitted by a pharmaceutical company, when they are considered clinically important to NHS Scotland.
Neil said, “We have listened carefully to patients, charities and consultants and put in place a comprehensive range of measures which will increase access to new medicines and make the system better and more open for patients.
“The SMC has a pivotal role in ensuring new medicines are thoroughly assessed for clinical effectiveness,” Neil said. “However, the Scottish Parliament Health and Sport Committee recognized that the existing assessments are not always appropriate for medicines for use at end of life or for medicines to treat very rare diseases.
“I’ve directed the SMC to conclude a review by the end of the year to establish more flexible approaches in evaluating medicines for end-of-life care and treating very rare conditions to increase access to new medicines for Scottish patients,” said Neil.
The SMC will report its findings to the Cabinet Secretary before year end, so the new, more flexible approach can be implemented in early 2014.