UK: The UK Has An Opportunity To Take Global Lead On Regenerative Medicines, Says Expert

Last Updated: 8 May 2017
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The UK has the potential to be a global leader in regenerative medicine, an expert has said.

Life sciences specialist Helen Cline of Pinsent Masons, the law firm behind, said a new report by a committee of MPs has highlighted that for that potential to be realised, agreement is needed on innovative approaches to commercialisation, which meet head-on the existing challenges around regulation, evaluation, funding and adoption.

"The last decade has seen considerable changes in the regenerative medicine industry but we are still some way off big transformative curative treatments – only 20 products were approved globally in 2016," Cline said. "These products are, however, complex, with a supply chain infrastructure that simply cannot be uprooted and moved elsewhere. The UK, therefore, needs to nurture a supportive environment now, with enough incentives and resources to encourage companies to invest in building the costly manufacturing facilities in the UK."

"In the post Brexit world, the Medicines and Healthcare products Regulatory Agency (MHRA) has the opportunity to become the go-to global regulator for regenerative medicine products; a leader in global standards, pushing for a more progressive and collaborative long-term global regulatory and adoption strategy," Cline said.

"Patent issues are also seen as a barrier to commercial investment and development of regenerative medicines and, post Brexit, there may be opportunities for the UK to create more certainty around the availability of patent protection for these products," she said.

Cline was commenting after the Science and Technology Committee in the UK House of Commons published a new report calling for the next UK government to do more to support the development of the regenerative medicines industry in the UK.

In its report, the Committee said that new financial models for reimbursing life sciences companies that develop regenerative medicines used in the NHS in England should be agreed after the next UK government takes office. The new "reimbursement payment models" should "take greater account of the value of regenerative medicine therapies that offer cures, reduce healthcare costs and make treatments available earlier to patients", it said.

The Committee urged the next government to agree the new reimbursement models in consultation with biotech companies, NHS England and the National Institute for Health and Care Excellence (NICE).

The Committee also urged the next government to lead work on the creation of "appropriate financial incentives to stimulate regenerative medicine research and innovation within the NHS". The incentives would "encourage more clinicians to become more involved in research", it said.

A new "'fast track' appraisal system for emerging regenerative medicine therapies" being worked on by NHS England and NICE should also receive support from the next government, the Committee said.

The next government should further look into how existing 'hospital exemptions' to EU regulations on advanced therapy medicinal products "might be adapted for the UK post-Brexit in order to reflect our own perspectives on the optimal balance between safety and accelerated access to cutting-edge technologies", it said.

Regenerative medicine has previously been defined by another UK parliamentary committee as "methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function". That committee cited examples such as "cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices".

In 2015, the Regenerative Medicine Expert Group (RMEG), which was tasked with making recommendations to shape a new NHS regenerative medicine strategy, set out steps that it said should be taken to help researchers develop and clinicians utilise technologies that improve the human body's ability to repair itself.

Among other recommendations, the RMEG called for streamlined regulation and the establishment of "an innovative business model that supports the early adoption of regenerative medicines". It also said reviews should be carried out on "the funding for excess treatment costs for cell therapy trials" with the aim of finding "a mechanism ... to ensure that meeting of these costs is not a barrier to clinical trials or the early adoption of technologies".

In its new report, the Science and Technology Committee said that the next UK government should build on the RMEG's recommendations.

"While the government has responded and made progress through investment in further research and in setting up the Cell and Gene Therapy Catapult, there is still more work to be done," the Committee said. "A strategy is needed that covers the entire value chain – academic research, commercial development and clinical application – if the UK is to respond to the challenges of our healthcare system as well as facilitate economic growth."

The Committee said that a new strategy for advanced therapies should be developed and include regenerative medicine and cell therapies. It said the strategy should align with the existing government's response to the Accelerated Access Review and "strategic objectives" outlined in the government's industrial strategy, which was published earlier this year.

The Committee also called on NHS England to "explicitly" account for regenerative medicine in a new personalised medicine strategy it is working on.

"This would send a strong signal to the sector of the NHS's commitment and willingness to adopt new and emerging therapies," it said.

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