This was a renewed application by the claimants for permission to proceed with a judicial review challenge to the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021, which requires a registered person who runs a regulated activity in a care home to ensure that any person entering the premises has been vaccinated, unless for clinical reasons that person is exempt.
These new regulations regarding the mandatory vaccination of care workers came into effect on 11 November 2021. The claimants, both employed by care homes, challenged the legality of these regulations (passed under the Health and Social Care Act 2008). Whilst the claimants accepted that the 2021 Regulations fell within the scope of the 2008 Act, they argued that s.45E of the Public Health (Control of Disease) Act 1984 was engaged and, when the provisions are read together, s.45E precludes Regulation 5(3)(b). Section 45E provides that Regulations made under s. 45B or s. 45C may not include provision requiring a person to undergo medical treatment.
This was one of those deeply troubling cases where there was disagreement amongst the family members over whether their incapacitated brother/father should continue with clinically assisted nutrition and hydration. One brother had applied for ANH to be discontinued, but because of the objections of the patient’s son, it was said that he would “continue to be cared for by nursing staff”.
As Hayden J observed, this was a “troubling non sequitur”:
Family dissent to a medical consensus should never stand in the way of an incapacitated patient’s best interests being properly identified. A difference of view between the doctors and a family member should not be permitted to subjugate this best interest investigation.
This particular hearing was ex post facto: in 11th June 2021, Hayden J delivered an extempore judgment in which he indicated why the continued provision of nutrition and hydration to GU, in the manner outlined above, was contrary to GU’s interests. However, having concluded that it was not in GU’s best interests to continue to receive CANH at the hearing on 11th June 2021, he considered it was necessary to afford RHND the opportunity of explaining what had happened. Amelia Walker of 1 Crown Office Row represented the hospital in these proceedings.
On the one hand, there are raptors. On the other there are game birds. The former are highly protected under statute. The latter bring in serious revenues to rural businesses for shoots. Hen Harriers (image right) are dependent on, amongst other things, the protein from grouse chicks for their young.
On the cuteness scale, I know who wins, wings down.
But here we have it. The voracious teenagers that you see in the first paragraph are the protected species. The fluffy number in image 2 is a designated target for paying hunters, as well as mother hen harriers.
This case was an appeal by the RSPB and Dr Mark Avery, a scientist specialising in nature conservation, against a ruling by the court below that the grant of a licence by the respondent, Natural England (NE), to “take and disturb” hen harriers from the Northern English uplands for scientific, research or educational purposes pursuant to the Wildlife and Countryside Act 1981 Pt I s.16(1)(a) was lawful.
Background law and facts
Under Article 4 of Directive 2009/147 on the conservation of wild birds, EU Member States are required to designate special protection areas (SPAs) for their conservation. There are two such SPAs in England.
Under this network of rules it is a criminal offence to disturb these protected birds. Nevertheless they have been persecuted: killing and nest destruction by contractors employed to maximise the number of grouse available for shooting in the autumn.
In an effort to resolve the impasse between conservationists and landowners running shoots, NE in 2015 recommended piloting a “brood management scheme”, whereby eggs and chicks would be removed from the parental hen harrier nests, reared in captivity and then released when they were fully fledged into a suitable habitat, away from the grouse moors. NE duly received a licence application in 2017, on which they carried out a Habitats Regulations Assessment pursuant to Regulation 63 of the Conservation of Habitats and Species Regulations 2017. This report did turn up a potential decrease in breeding and juvenile survival as the principal risk of the trial and suggested potential mitigation. Apparently no such mitigation was available. So the NE completed a Technical Assessment and concluded that there was no satisfactory alternative to the proposed scientific trial.
The first licence for relocation of eggs and chicks was granted in January 2018.
A “HeLa” cell is, or was, the name of a cell from a line of fast producing cancer cells that was taken from the tumour of a patient who died of cervical cancer at Johns Hopkins Hospital in 1951. These cells reproduce at such a rate they have been described as “immortal” and they have touched all corners of medical research and therapy in the past seven decades. They’ve formed the basis of the polio vaccine; they’ve helped with research into IVF and infertility as well as HIV. They were of tremendous importance to medicine then and medicine now.
Henrietta Lacks’ family, once they were made aware of the continuing research on her cells, have made various efforts to claim reparations for this non-consensual use of her body parts. The estate has now launched proceedings against Thermo Fisher, the pharmaceutical company that bought the cells from the hospital at the time; see my previous post on this lawsuit here.
In Episode 152 of Law Pod UK I discuss this case with Jacob Serco, Professor of Law at the College of Law and a specialist in genomic biology at the University of Illinois, where his research focuses on the legal and ethical implications of advanced biotechnologies, especially as related to intellectual property. He is a leading expert on IP protection for genome-editing technologies, including CRISPR.
Professor Serco provides an illuminating guide to the US law on biotechnology in this episode and we discuss the prospects of this particular lawsuit. But this is only the latest of a series of episodes in which Henrietta Lacks’ cells have been in the limelight. In October last year the Lacks foundation received a “six figure” donation from the Howard Hughes Medical Institute by way of “reparation”; in 2013 the US National Institute of Health settled upon a new agreement under which Lack’s genome data would be accessible only to those who apply for and are granted permission. The modern interest in her case was sparked by the book by Rebecca Skloot about her case. The Immortal Life of Henrietta Lacks stayed on the NYT bestseller list for two years and was followed by a film of the same name.
In the latest Episode of Law Pod UK Rosalind English talks to Robert Kellar QC of 1 Crown Office row about the proposed reforms to the regulation of doctors, nurses, opticians, chiropractors and a range of other professionals in the world of healthcare. It’s particularly important to allow regulators to react to unexpected challenges, as we’ve found since the recent Covid-19 emergency.
As Robert explains, the proposals directed at overhauling the system of professional healthcare regulation aim to introduce greater consistency across the regulatory bodies (we have an impressive nine organisations at the moment). Whether this and other proposals to increase the autonomy of these bodies will increase public safety whilst still respecting practitioners’ rights remains to be seen.
Here are the links to the Government White Paper and the Consultation Paper discussed in Episode 151:
In Episode 150 Rosalind English talks to Professor Ryan Abbott about the recent ruling in the Court of Appeal on whether an invention made by Artificial Intelligence without a traditional human inventor is entitled to a patent. The Court (with one of the judges dissenting) said no.
Ryan Abbott is the author of The Reasonable Robot: Artificial Intelligence and the Law published last year and he has published widely on issues associated with law and technology, health law, and intellectual property in leading legal, medical, and scientific books and journals. He is also a licensed physician, attorney, and acupuncturist in the United States, as well as a solicitor advocate in England and Wales.
He is also architect of this important test case. We discuss the obstacles faced by the inventor of an AI set out in the Patents Act 1977 and speculate whether there needs to be a root and branch review of patent eligibility, given that so many inventions are produced by AI across the world.
Henrietta Lacks was a young Black woman who in 1951 was diagnosed with a particularly agressive form of cervical cancer. Her treating doctors at the Johns Hopkins hospital took a sample from the tumour and that was the birth of “HeLa” – an “immortal” line of fast-replicating cells that have been reproduced every since, used in scientific and medical innovations including the development of the polio vaccine, infertility research and even the early research into a vaccine against Covid19. The HeLa cell line was in essence the first time human cells could be successfully cloned and it has been in use continually for research that has touched nearly every realm of medicine.
In October 2021, her estate filed suit against Thermo Fisher, the pharmaceutical company that bought the cells from the hospital. Her family, represented by Ben Crump, the attorney who represented the family of George Floyd in 2020, is asking the company to pay back the full profits gained over 70 years of using her cells without consent. This is the US remedy of “disgorgement of profits”, which essentially involves the transfer of all the company’s patents and profits from the HeLa line to the Lacks estate. In essence, disgorgement removes the incentive to unjustly enrich yourself at another’s expense.
The problem with this remedy is it is dependent on the enrichment being based on the other person’s property. In US law, as in the UK, there is no property in the body. In fact US law is silent on ownership of bodily resources. The only statute that governs this subject is the 1984 National Organ Transplant Act which bans the sale of all organs including kidneys. The ban only extends to the sale of kidneys for transplantation; there is no ban on the sale of kidneys for research and experimentation.
The Court of Appeal has ruled that an artificial intelligence machine cannot qualify as an “inventor” for the purposes of Sections 7 and 13 of the Patents Act because it is not a person. Further, in determining whether a person had the right to apply for a patent under Section 7(2)(b), there was no rule of law that new intangible property produced by existing tangible property was the property of the owner of the tangible property, and certainly no rule that property in an invention created by a machine was owned by the owner of the machine.
Background Facts and Law
This was an appeal by the owner of an artificial intelligence machine against a decision upholding the respondent Comptroller’s refusal of his patent applications in respect of inventions generated by the machine.The appellant had submitted two patent applications designating an artificial intelligence machine (DABUS), as the inventor. DABUS stands for “Device for the Autonomous Bootstrapping of Unified Sentience”, an artificial neural system owned by Dr Thaler. The first invention was entitled “Food Container” and concerned the shape of parts of packaging for food. The second was entitled “Devices and Methods for Attracting Enhanced Attention”, and was a form of flashing light. On the face of it each disclosed a potentially patentable invention, that is to say patentable as defined by s1 of the 1977 Act. The appellant owned the machine, but had also created it and set it up to produce the inventions in issue. In response to the box requiring him to indicate how he had the right to be granted a patent, he wrote: “by ownership of the creativity machine ‘DABUS'”. The Intellectual Property Office indicated that the statement of inventorship form did not satisfy the Patents Act 1977 Pt I s.13(2), which required him to identify a person as the inventor (section 13 (2) (a) and to indicate how he had derived his right to be granted the patent (section 13(2) (b)). It therefore determined that the applications were deemed to be withdrawn. The applicant was still not entitled to apply for a patent simply by virtue of ownership of DABUS, because a satisfactory derivation of right had not been provided (as machine cannot pass on ownership). The High Court upheld that decision. First, it considered Section 7, which sets out the circumstances in which a person might right to apply and obtain a patent, and found that its natural meaning was that the inventor was a person. Second, it found that although the appellant could perhaps have claimed a right to be granted a patent as the inventor under Section 7(2)(a), he had not advanced such a case. Third, it found that an applicant’s subjective and honest belief that they were entitled to apply for a patent was insufficient to entitle them to the grant of a patent as that would render the provisions of s.7 otiose.
And you will notice a few changes: different signature tune, different voiceover: our very own head of Chambers, Richard Booth QC. Also welcome to our new producer Philip at lawpodcasts.co.uk, who’s done a great job taking over the task of delivering this podcast from Simon Jarvis of Whistledown.
We have a terrific line up of guests following Angus for the Autumn.
These are the words that Hayden J, Vice President of the Court of Protection, used to describe AH, the applicant in this case. The Official Solicitor identified it as “the most troubling and tragic of cases of this kind” with which she has been involved.
This case is the most recent and cogent in the consideration of best interests under the Mental Capacity Act in terms of continuing life-saving treatment. The “best interests” test is laid out in Aintree University Hospital NHS Trust v James  UKSC 67.
AH’s family was originally from Pakistan. She and her family moved to Uganda but they were expelled, as South Asian residents, under the Idi Amin regime, in the early 1970’s. AH’s medical history showed signs of non-specific arthralgia, raised calcium levels and Type 2 diabetes. She had been diagnosed with carpal tunnel syndrome. She did not smoke, nor did she drink alcohol.
In early January 2020 she suffered a high fever which her doctors identified symptomatic and not causative of the cytokine/autoimmune ‘storm’ which created the “devastating” neurological damage and the pathological processes she has suffered from since. Both her treating doctors had seen similar cytokine ‘storms’ in patients critically ill with Covid-19 although neither has seen damage as extensive as that sustained by the applicant. All agreed that it was in consequence of this ‘storm’ that there had been such “extensive damage” to the nerves and to the muscle as well as to the brain.
I have posted on the extraordinary goings-on in Thuringen, Germany where two Weimar judges, one family and one administrative, have been subject to searches by the public prosecutor’s office following their respective rulings containing comments critical of the various lockdown and testing measures during the C-19 pandemic. You can find my posts here, here and here.
So it’s something of an irony that, whilst a leading member state of the European Union is going after its judges for rulings of which it disapproves, the European Commission lodges an application for interim measures under Article 279 TFEU and Article 160(2) of the Rules of Procedure, requesting that the European Court of Justice order the Republic of Poland to suspend various Polish laws concerning disciplinary cases against judges. As the ECJ said, when considering the request,
The European Union is composed of States which have freely and voluntarily committed themselves to the common values referred to in Article 2 TEU, which respect those values and which undertake to promote them. In particular, it follows from Article 2 TEU that the European Union is founded on values, such as the rule of law, which are common to the Member States in a society in which, inter alia, justice prevails.
Fine words, indeed. But the aspiration needs some enforcement. On the 15th of July the European Court of Justice (ECJ) ruled that the moves by the Polish government to institute a “Disciplinary Chamber of the Supreme Court” interfered with the guarantees of impartiality and independence of the judiciary, as well as the protection of the judiciary from executive disciplinary action, was in breach of EU law (Case C‑791/19, action for failure to fulfil obligations under Article 258 TFEU).
The Federal Court of Justice in Germany (the Bundesgerichtshof, or BGH) has ruled against the social network provider that deleted posts and suspended accounts amid allegations of “hate speech”.
The ruling was handed down on the 29th of July (Bundesgerichtshof, Urteile vom 29. Juli 2021 – III ZR 179/20 und III ZR 192/20) and at the time of writing this post, the full judgment had not been published. The following summary is based upon the Bundesgerichtshof’s press release. NB the quotes from the plaintiff’s Facebook entries are in the judgment, i.e. the public domain, in other words no offence is intended by repeating them here.
Judgments of July 29, 2021 – III ZR 179/20 and III ZR 192/20
The III Civil Senate of the German Federal Court of Justice has ruled that Facebook’s terms and conditions of April 19, 2018 for the deletion of user posts and account blocking in the event of violations of the communication standards set out in the terms and conditions are invalid. This was because the defendant provider had not undertaken to inform the user about the removal of his post at least subsequently and about an intended blocking of his user account in advance, had not informed them of the reason for this and had not given them an opportunity to respond with a subsequent new decision. If, due to the invalid terms and conditions of the provider’s contract, a user’s contribution was deleted and their account temporarily subject to a partial blocking, the user should be able to claim the activation of the deleted contribution and, an undertaking that there would be no further account blocking or deletion of the contribution upon its renewed posting.
The parties disputed the legality of a temporary partial blocking of the plaintiffs’ Facebook user accounts and the deletion of their comments by the defendant.
The plaintiffs each maintained a user account for a worldwide social network operated by the defendant’s parent company, whose provider and contractual partner for users based in Germany was the defendant. They claimed against the defendant – to the extent still relevant for the appeal proceedings – in respect of activation of the posts published by them on the network and deleted by the defendant, for an injunction against renewed blocking of their user accounts and deletion of their posts, and – in one of the appeal proceedings – for information about a company commissioned to implement the account blocking.
The ability to make interim care orders under s.38 Children Act 1989 is one of the family court’s most significant powers. With newborn babies, prompt action is not only desirable, it’s essential. But not so easy to achieve in practice, as you will hear from our lively and comprehensive conversation.
This episode will be the last before we take our August break, but plans for Law Pod UK from September are already being hatched so remember to tune in!
The focus of this judgment was on the jurisdiction, if any, that the High Court Family Division has to maintain a Reporting Restriction Order (‘RRO’) prohibiting the naming of any medical clinicians as being involved in the care and treatment of a child who had been the subject of “end of life” proceedings before the High Court prior to their death, and where an RRO had been made at that time preventing the identification of any of the treating clinicians and staff until further order.
Each of the children, Zainab Abbasi and Isaiah Haastrup, had been the subject of end of life proceedings under the inherent jurisdiction of the High Court, in which the issue was whether life-support should be withdrawn from them. Each of the two children died; Zainab Abbasi dying after the issue of proceedings but before the court could conduct a substantive adjudication, and Isaiah Haastrup dying following the removal of life-sustaining ventilation at the conclusion of a full legal process including an application to the Court of Appeal. In both cases, widely drawn RROs were made during the proceedings.
The offence of “Rechtsbeugung” in German law is not easy to translate. The best match we have for it in English is the offence of “misconduct in public office”. Misfeasance in public office, according to Archibold, is committed by
(a) a public officer acting as such who
(b) wilfully neglects to perform his duty and/or wilfully misconducts himself
(c) to such a degree as to amount to an abuse of the public’s trust in the office holder,
(d) without reasonable justification.
I have not been able to find any examples of judges being prosecuted for misconduct in public office in this country. However, this past fortnight in Germany, no less than eight searches have been carried out in the homes of judges, their expert witnesses, a guardian ad litem and others associated with a controversial ruling regarding Covid-19 restrictions. I posted on Judge Christian Dettmar’s ruling in early April and subsequent investigation here. Reminder: Judge Dettmar issued an injunction against two schools in Weimar to stop them imposing masking, social distancing and testing. This was in his view necessary in order to avert (further) compromising of children’s welfare.
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