An untested plague vaccine could be one of the five to ten products per year expected to be given a special status in the UK under new rules.
Generation of real-world evidence in addition to clinical trials data.

The new accelerated access pathway seems to allow for the uncontrolled and dangerous experimentation on people, in “real time”, instead of insisting on a planned clinical trial.

A plague vaccine might be given to people, including patients as part of the new NHS test bed programme.

Sir Andrew Witty, chief of GSK when the company’s swine flu vaccine injured youngsters throughout Europe, is to oversee the committee which steers the process and decides of the success of a product.

The same government which has just unveiled this streamlined process for giving patients untested jabs also fought compensation for those injured by the untested swine flu jab all the way to the High Court.

A study makes it clear that at least for medical devices, including digital devices, the new process will allow for a self declaration and an assessment process that is “not a regulatory process.”

“As at present, if a product meets the definition of a medical device it will need to be CE marked in accordance with the Medical Device Directives. For these products, a developer can still choose on a voluntary basis to undertake the Paperless 2020 assessment process, once the CE mark has been obtained. The Paperless 2020 assessment process itself is not a regulatory process.”

From The Telegraph

 3 November 2017 • 12:01am  

Drug firms will be offered a fast-track route to get “breakthrough” medicines to NHS patients up to four years early under a new Government system to be overseen by former GSK boss Sir Andrew Witty.

The scheme, launching from April next year, will see approvals for cutting-edge treatments for conditions like cancer, dementia and diabetes dramatically sped up.

Promising drugs will receive “breakthrough” designation, unlocking a package of public sector support from clinical development help through to faster commercial deals with the NHS.

The Accelerated Access Pathway initiative is in part the Government’s answer to a long-held industry complaint that British patients get a raw deal when it comes to accessing the latest medicines.

Pharmaceutical leaders welcomed the move, including the appointment of Sir Andrew Witty – who led Britain’s biggest drugmaker GSK for nine years until April this year – as chairman of the Accelerated Access Collaborative body that will steer the system.

Dr Richard Torbett, executive director of the Association of the British Pharmaceutical Industry, said the commitment was “very much welcome”.
Generation of real-world evidence in addition to clinical trials data.

We are also seeing new and innovative partnership arrangements. Last January we
launched the Test Bed programme, demonstrating how industry and the NHS can work
in collaboration. Through this unique approach we have established seven sites across
the country, supported 40 innovations and have about 4,000 patients enrolled. Test
Beds demonstrate success throughout the innovation pipeline: from supporting the
development of devices and technologies, integrating them in new ways, and working
with health professionals to adapt and develop new clinical and care pathways. It is early
days for the test beds, and by the very nature of innovation, we expect that some will be
more successful than others, but the evidence shows compelling signs of improvement
to patient care outcomes. NHS England and Government have committed further
funding to support the extension of the programme for another two years.

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