HDA UK Media and Political Bulletin – 23 August 2021
There was no media coverage today.
First monoclonal antibody treatment for COVID-19 approved for use in the UK
Medicines and Healthcare products Regulatory Agency and The Rt Hon Sajid Javid MP – 20 August 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ronapreve as the first monoclonal antibody treatment for the prevention and treatment of COVID-19 in the UK.
Developed by Regeneron/Roche, the drug is administered either by injection or infusion and acts at the lining of the respiratory system where it binds tightly to the coronavirus and prevents it from gaining access to the cells of the respiratory system.
Clinical trial data assessed by MHRA scientists and clinicians has shown that Ronapreve may be used to prevent infection, promote resolution of symptoms of acute COVID-19 infection and can reduce the likelihood of being admitted to hospital due to COVID-19.
Health and Social Care Secretary Sajid Javid said: “We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.
Interim Chief Quality & Access Officer, Dr Samantha Atkinson said: “Ronapreve is the first of its kind for the treatment of COVID-19, and after a meticulous assessment of the data by our expert scientists and clinicians, we are satisfied that this treatment is safe and effective.”
New proposals to strengthen medical devices regulation and bolster UK life sciences sector
Department for Business, Energy & Industrial Strategy – 19 August 2021
A new report published by the Regulatory Horizons Council highlights opportunities for the UK to create its own specific regulations that puts patients first, following the UK’s departure from the EU.
These new proposals aim to strengthen the regulation of medical devices in the UK and support the life sciences sector to tackle future health challenges, incorporating the lessons learnt from the COVID-19 pandemic. This includes addressing delays in medical device approval so that equipment can be authorised effectively and at speed
The report recognises Brexit as an opportunity to build a UK-specific regulatory system that puts patients at the heart of decision-making processes. Additionally, it presents opportunities now available to the UK, including, responding more quickly to new advances in technology and shaping international regulation.
Life Sciences Minister Nadhim Zahawi said: “Our life sciences industry is at forefront of global, modern regulation, as demonstrated by the speed and flexibility of the UK’s development and rollout of COVID vaccines.”
Innovation Minister Lord Bethell stated: “The UK’s brilliant life sciences sector has excelled during the pandemic, pioneering important research and developing vaccines and treatments for COVID-19 which have saved countless lives across the globe.”
Additionally, Lord Bethell highlighted that the Medicines and Healthcare products Regulatory Agency (MHRA) was the first in the world to approve a COVID-19 vaccine and will soon be outlining proposals for a new regulatory framework for medical devices which will prioritise safety and help UK patients benefit from cutting-edge medical technology.
There was no media coverage today.
From Factory to Pharmacy
As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.See the Infographic
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