MHRA suspends recruitment to COVID-19 hydroxychloroquine trials

Press release

The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants.

Hydroxy

This means that no new participants will be recruited to these trials until further data which justifies their continuation have been provided, and any additional safety measures have been implemented.

This decision follows advice from the Commission on Human Medicines, which met on 1 and 5 June 2020 and reviewed the data that had been submitted for each trial in response to MHRA requests.

We followed the emerging concerns about use of hydroxychloroquine in COVID-19, and took into consideration the results from two different trials, including the UK’s RECOVERY trial which has provided convincing evidence of no meaningful mortality benefit in hospitalised patients with COVID-19.

Dr June Raine, MHRA’s CEO, said:

We have told those conducting clinical trials using hydroxychloroquine to treat or prevent COVID-19 to suspend recruitment into their trials.

Neither hydroxychloroquine nor chloroquine are licensed to treat COVID-19 related symptoms or to prevent infection.

It is important to note that patients taking hydroxychloroquine and chloroquine to treat other health conditions can continue to do so, as advised by their healthcare professional, as the balance of benefits and risks remains favourable in the licensed uses.

Hydroxychloroquine and chloroquine licensed in the UK

Hydroxychloroquine and chloroquine are licensed in the UK to treat different health conditions such as malaria, rheumatoid arthritis, lupus, amoebic hepatitis and abscess and certain dermatological conditions. These products should only be taken if prescribed by a healthcare professional and supplied by or under the supervision of a pharmacist on registered pharmacy premises.

Patients or healthcare professionals can report any suspected side effects from hydroxychloroquine or chloroquine taken by patients with COVID-19 via our Yellow Card COVID-19 reporting site.

If you would like to report any suspected side effects from hydroxychloroquine or chloroquine taken to treat other health conditions, please use our main Yellow Card site

Notes to editor

  • There is currently no medicine specifically licensed for the treatment of Covid-19. See our guidance on chloroquine/hydroxychloroquine and COVID-19.
  • The MHRA took into consideration the results released from the RECOVERY trial, showing no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19, and a New England Journal of Medicine publication using hydroxychloroquine as postexposure prophylaxis of COVID-19, concluding that hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection.
  • Medicines and Healthcare products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. 
  • The MHRAis a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care
  • The Commission on Human Medicines (CHM) is a committee of the Medicines and Healthcare Products Regulatory Agency. The CHM advises ministers on the safety, efficacy and quality of medicinal products.
  • The Yellow Card COVID-19 reporting site. is a separate platform dedicated to COVID-19 related reports and linked to the main Yellow Card scheme reporting site. Information provided by patients and healthcare professionals through their COVID-19 Yellow Card reports will be used alongside other scientific safety information such as clinical trials, scientific literature, other safety databases and studies to help MHRA to take action, if necessary, to make changes to the warnings given to people taking a medicine or review the way a medicine or a device is used to maximise benefit and minimise the risk to the patient.  
  • The Yellow Card scheme is MHRA’s system of monitoring the safety of medicines and medical devices in the UK and it acts as an early warning system to identify new, and strengthen existing, safety information about medicines, medical devices, falsified or defective healthcare products, and e-cigarettes.  
  • There currently are no vaccine and no medicines authorised to treat COVID-19 in the UK by the MHRA. However, several treatments authorised for other diseases are being used in patients with COVID-19.  

Published 16 June 2020




Joint statement on Djibouti talks between Somalia and Somaliland leaders

World news story

Somalia international partners welcome the commitment of the two leaders to continue the dialogue.

Joint statement on Djibouti talks

The below statement was signed by United Kingdom, European Union, Finland, France, Germany, Italy, Japan, Netherlands, Ireland, Norway, Sweden, Switzerland, Turkey, Uganda, United States, Belgium, Canada, China, Denmark, Ethiopia, United Nations, Intergovernmental Authority on Development (IGAD) and the African Union Mission in Somalia (AMISOM).

Somalia’s international partners welcome the dialogue between President Mohamed Abdullahi Mohamed ‘Farmajo’ and President Muse Bihi Abdi, hosted by President Ismail Omar Guelleh of Djibouti, and attended by Ethiopian Prime Minister Abiy Ahmed Ali. We commend the regional support, and engagement that led to the talks.

We welcome the meeting as an important step in strengthening communication and fostering understanding, and encourage the technical committee named by the principals to deliver tangible benefits for their people.

Published 16 June 2020




Geospatial Data Strategy to unlock the power of location data across the UK’s Blue Economy

Geospatial, or location data, is having a significant impact on our lives. It is transforming the way we complete everyday tasks, supports key decisions on where to develop vital infrastructure and helps us to use resources efficiently.

This data is also critical to the way we interact with and protect our oceans. Whether renewables or shipping, much of our maritime sector depends on data depicting the marine environment to operate and work safely. This same data is also essential to the protection of our oceans, helping us to monitor delicate marine environments and use them responsibly.

The UK Geospatial Strategy, released this week by the Geospatial Commission, sets out key steps that will help to unlock the power of location data across land and sea – building economic, social and environmental value for the UK. This includes 4 key missions that the Commission will use to increase access to data, build skills and support innovation over the next 5 years. These include:

  • Promote and safeguard the use of location data to provide an evidenced view of the market value of location data, set clear guidelines on data access, privacy, ethics and security, and promote better use of location data.

  • Improve access to better location data to streamline, test and scale the development of new and existing location data ensuring it is findable, accessible, interoperable, reusable and of high quality.

  • Enhance capabilities, skills and awareness to develop more people with the right skills and tools to work with location data – across organisations and sectors – to meet the UK’s future needs and support global development.

  • Enable innovation to maximise commercial opportunities and promote market-wide adoption of high value emerging location technologies.

Together, these missions will help drive innovation and boost the economy across the UK over the coming years. This includes our maritime sector, which provides an estimated £47 billion to the economy each year.

As one of 6 partner bodies, the UK Hydrographic Office is proudly supporting this strategy and its aims. We will work with other members of the Geo6 to improve the way geospatial data is used and shared in the UK.

You can view and download the full strategy here.

Commenting on the strategy Tim Lowe, Chief Executive of the UK Hydrographic Office, said:

The launch of this strategy is an exciting milestone for the UK and will enable a transformation in the way we understand and utilise our geospatial data.

For many of our marine industries, this geospatial data is an everyday essential. So, by improving access to this data, building skills and supporting innovation, we can help these industries to thrive whilst tackling environmental and social concerns.

As a partner body, we’re proud of the part we’ve played. But I would also like to thank the UK’s marine geospatial community, whose input has helped to build this strategy. Working together, we can unlock the power of location data and enable better use of our seas and oceans.

Cathrine Armour, Chief Customer Officer at the UK Hydrographic Office commented:

There is a growing recognition of the importance of our marine environment and the need to use ocean resources in a sustainable way. Marine geospatial data is essential to help us unlock economic value, whilst ensuring the protection of our oceans for years to come.

The exciting steps outlined in this strategy will help to improve access to this data and build geospatial skills across the UK, enabling the UKHO and our partners to develop safe, secure and thriving oceans into the future.




UK designing new rover to bring first samples back from Mars

News story

Airbus UK has won the next phase of the study contract to design the Sample Fetch Rover for the European Space Agency (ESA)

Artist's impression of sample return mission on Mars

Credit: NASA/JPL-Caltech

The UK space sector has world-leading expertise in robotic space exploration, with Airbus completing the build of the ‘Rosalind Franklin’ rover last year.

This new contract will see UK scientists and engineers working on the next Mars ‘Sample Fetch Rover’ as part of a joint NASA and ESA campaign to collect samples from Mars and return them to Earth.

Airbus in Stevenage is leading the Sample Fetch Rover project and has already completed two preliminary studies, to develop sophisticated algorithms to help the rover spot the samples and a robotic arm to pick them up.

The plan is for the rover to launch in 2026 and land on Mars in 2028. Once there, it will collect up to 36 soil, rock and atmospheric samples left behind by NASA’s 2020 Perseverance rover, before transferring them to a Mars Ascent Vehicle to begin their journey back to Earth for study.

Graham Turnock, Chief Executive of the UK Space Agency, said:

This is an exciting opportunity for the UK space sector to play a leading role in humanity’s efforts to return the first samples from Mars. Airbus has a rich heritage of designing challenging space missions in the UK, from the Solar Orbiter probe to the ‘Rosalind Franklin’ Mars rover.

The government has made clear its ambitions for space and we are working hard to develop a new National Space Strategy to bring long-term strategic and commercial benefits to the UK, while strengthening our international partnerships through ESA and beyond.

In November 2019, the UK committed £180 million to ESA’s global exploration programme to ensure UK industry plays a leading role in this mission to bring back the first samples from Mars and supports NASA’s ambitions to return humans to the Moon.

Further details

Published 16 June 2020




Prime Minister announces merger of Department for International Development and Foreign Office

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The Prime Minister has announced that DFID and the FCO will merge, uniting development and diplomacy in one new department that brings together Britain’s international effort.

Work will begin immediately on the merger. The new department – the Foreign, Commonwealth and Development Office – will be established in early September and will be led by the Foreign Secretary.

The merger is an opportunity for the UK to have even greater impact and influence on the world stage as we recover from the coronavirus pandemic and prepare to hold the G7 presidency and host COP26 next year.

UK aid will be given new prominence within our ambitious international policy. The Foreign Secretary will be empowered to make decisions on aid spending in line with the UK’s priorities overseas, harnessing the skills, expertise and evidence that have earned our reputation as a leader in the international development community.

The UK is the only G7 country to spend 0.7% of GNI on overseas development and the Government remains committed to this target, which is enshrined in law.

Announcing the new department, the Prime Minister said:

This is exactly the moment when we must mobilise every one of our national assets, including our aid budget and expertise, to safeguard British interests and values overseas.

And the best possible instrument for doing that will be a new department charged with using all the tools of British influence to seize the opportunities ahead.

The Prime Minister has also announced that the UK’s Trade Commissioners will come under the authority of UK Ambassadors overseas, bringing more coherence to our international presence.

The objectives of the new overseas department will be shaped by the outcome of the Integrated Review, which is expected to conclude in the autumn, and is the biggest review of foreign, defence and development policy since the Cold War.

A checked against delivery version of the PM’s statement to Parliament can be found here.

Published 16 June 2020
Last updated 17 June 2020 + show all updates

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