‘The 2021 version of the ABPI Code will come into effect on 1 July. This brings in important changes to the self-regulatory system for the UK pharma industry. It amounts to the most substantial refresh of the Code since the 1990s.’
Mills & Reeve, 4th June 2021
Source: www.mills-reeve.com
‘The Medicines and Medical Devices Act has now become law. Much of the legislation simply sets up powers and frameworks for development of the UK’s regulatory system for medicines, veterinary medicines and medical devices. Importantly, Part 4 of the Act introduces a new enforcement regime for medical devices, replacing provisions currently scattered across other legislation.’
Mills & Reeve, 5th March 2021
Source: www.mills-reeve.com
‘Sophie Basma (“Sophie”) is 10. She suffers from Type 3 Spinal Muscular Atrophy (“SMA”). SMA is a rare, genetic, neuromuscular disease which progressively leads to sufferers being unable to walk or sit unaided with devastating consequences on their quality of life. Sophie can no longer walk. There is medication for SMA sufferers which would have had the potential of helping Sophie regain her ability to work. But the NHS Trust had concluded that Sophie did not meet the eligibility criteria for this new medication, “Nusinersen”.’
UK Human Rights Blog, 4th March 2021
Source: ukhumanrightsblog.com
‘A pharmacist who illegally sold addictive prescription pills valued at more than £1m on the black market has been jailed for 12 months.’
BBC News, 2nd March 2021
Source: www.bbc.co.uk
‘Prisoners should be given cannabis to help deal with addiction problems and tackle violence, according to a police and crime commissioner (PCC) in Wales.’
The Independent, 28th February 2021
Source: www.independent.co.uk
‘On 1 February, AstraZeneca told the EU that it would deliver around 50% of the 80 million COVID-19 vaccine doses that it had previously told the EU for the first quarter of 2021.’
The 36 Group, 10th February 2021
Source: 36group.co.uk
‘Relatives of patients who died after receiving “dangerous” levels of painkillers at Gosport War Memorial Hospital have called for new inquests.’
BBC News, 5th February 2021
Source: www.bbc.co.uk
‘In Episode 128 Emma-Louise Fenelon talks to Marina Wheeler QC about the Cumberlege Review, which investigated the response of England’s healthcare system to patients’ reports of harm from drugs and medical devices.’
Law Pod UK, 22nd October 2020
Source: audioboom.com
‘The death of a teenager who was given antipsychotic medication though he and his family warned that the drug might cause him serious harm could have been avoided, an independent review has concluded.’
The Guardian, 20th October 2020
Source: www.theguardian.com
‘The parents of a toddler with severe epilepsy are seeking a landmark judicial review of rigid guidelines that effectively prevent the NHS from prescribing medical cannabis oil, a substance that they say has allowed their son to live a much healthier life, to thousands of sick children.’
The Guardian, 16th August 2020
Source: www.theguardian.com
‘This was an application by the GPhC to extend interim orders for the suspension of the respondent husband and wife pharmacists who were co-directors of a company which owned three pharmacies.’
Park Square Barristers, 6th July 2020
Source: www.parksquarebarristers.co.uk
‘Regeneron Pharmaceuticals Inc filed patents for a new type of genetically modified mouse which was a hybrid version of the gene that produces antibodies, combining a section of the mouse’s genetic material with a section of the genetic material from a human. In 2013, Regeneron sued Kymab Ltd for infringements of its patents. Kymab was producing its own genetically modified mice, with a similar genetic structure to Regeneron’s mice. Kymab argued that the patents filed were invalid because they fell foul of a patent law rule called sufficiency which means that documents filed with the patent must be detailed enough to enable scientifically skilled readers to make the invention for themselves. The Court of Appeal upheld the patents and Kymab appealed to the Supreme Court.’
UKSC Blog, 24th June 2020
Source: ukscblog.com
‘‘Marketing Authorisation’ must be obtained in respect of any medicinal product that is to be sold, supplied or offered for sale or supply in the UK. This article looks at the different types of authorisation available, including when they might be appropriate for use in respect of the UK only before considering the process adopted in the UK for approving medicines into the market. It is designed to be a beginner’s guide to bringing new products to market in the UK as opposed to a full explanation of each step; ultimately how the application itself is make will depend on the product itself and the research behind it. If upon reading this article you gain an understanding of how to begin the Market Authorisation process, then this article has served its purpose.’
3PB, 4th June 2020
Source: www.3pb.co.uk
‘This was an application by Neurim Pharmaceuticals (1991) Ltd. (“Neurim”), the registered proprietor of European patent (UK) number 1441702 and Flynn Pharma Ltd. (“Flynn”) the proprietor’s exclusive licensee for an interim injunction to restrain until trial or further order the generics manufacturer, Mylan, from taking steps that might infringe that patent. The application was heard online by Mr Justice Marcus Smith on 20 May 2020. He handed down his judgment on 3 June 2020.’
NIPC Law, 4th June 2020
Source: nipclaw.blogspot.com
‘Marcus Pilgerstorfer QC has co-authored an article considering liability issues arising in relation to the production of medical products in response to the coronavirus pandemic.’
11KBW, 21st May 2020
Source: www.11kbw.com
‘There is currently an enormous international effort in progress to invent, test and obtain regulatory approval for a COVID-19 vaccine (or more accurately, a vaccine against SARS-CoV-2, the underlying virus). It is right to consider now, how such a vaccine will get regulatory approval, how such approval might be affected by BREXIT, and if no-fault vaccine damage schemes may apply to any such novel vaccine.’
Henderson Chambers, 18th May 2020
Source: www.hendersonchambers.co.uk
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