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22 April 2020
Physicians, nursing trade unions and constituents recently petitioned the French Administrative Supreme Court with interim measure requests for the protection of fundamental rights during the COVID-19 crisis, resulting in eight rulings.(1)
Such interim measures (ie, injunctions or suspension of regulations) can be ordered for urgent matters when it is necessary to safeguard a fundamental freedom. In the cases at hand, the petitioners notably raised concerns regarding the right to life, the safeguarding of human dignity, the right to health protection and the precautionary principle, which had been infringed by a public body in a serious and clearly illegal manner.(2)
The French Administrative Supreme Court was also petitioned for a suspension, on which it ruled on 7 April 2020.(3) In such cases, the court can decide to suspend an administrative act in urgent matters when serious doubt over the act's validity can be demonstrated.(4)
In the 22 March 2020 ruling, the claimant sought an injunction against the prime minister and the minister of health, so that they be ordered to establish a total lockdown (including the full suspension of public transport and all non-essential professional activities, and the provision of home supplies to the population).
The court first noted the existing confinement measures at the time of the ruling (orders and decree of 16 March 2020 on the prohibition of travel outside the home except in limited circumstances as well as on gatherings with the possibility for the state representatives to take stricter measures if necessary) and then considered that total confinement measures could not be adopted, as home supplies to the population could not be properly organised for logistical reasons and the fact that public transport remained necessary for certain essential activities.
The court found that, although the abovementioned orders and decree could not be interpreted as a serious and clearly illegal failure of the state to adopt appropriate measures, their inaccurate interpretation by the state or non-compliance therewith could be penalised.
As a result, the prime minister and the Ministry of Health were ordered to specify and reassess, within 48 hours, lockdown exemptions and to assess the risks to public health of maintaining open markets. Although this injunction was supported by the government, its lack of associated penalties limited its binding nature.
However, this ruling should be compared with two more recent rulings,(5) in which the court was asked to order the prime minister and the Home Office to take measures to ensure uniform controls and penalties relating to the nationwide lockdown during the COVID-19 crisis. These requests were denied on the grounds that the claimants did not demonstrate that decisions had been made to limit controls or not to penalise non-compliance with lockdown regulations in certain arrears.
In several cases,(6) the state was asked to take appropriate action to ensure the production of screening tests on an industrial scale, regulatory measures for medical staff testing and the supply of these tests to healthcare practitioners to allow mass testing of the population. A 4 April 2020 decision also concerned an order on screening tests in Guadeloupe.
Unions and constituents also requested measures to ensure the sufficient supply of personal protective equipment (PPE) (eg, masks (notably FFP2 and FFP3), hydroalcoholic gel and gowns) for healthcare practitioners. An injunction was also sought to ensure the sufficient supply of surgical masks to patients and the general population.(7)
The French Administrative Supreme Court seems to have adopted a different approach in assessing the burden of proof in these cases.
The court dismissed several claims, notably on the ground that they were insufficiently detailed. Regarding claims concerning PPE supplies – excluding masks for healthcare practitioners and the insufficiency of surgical masks for the general population – the court also considered that, due to limited stocks, surgical masks for healthcare professionals must be prioritised.
However, on the question of mask supplies and their distribution to healthcare practitioners, the court recognised the lack of sufficient stocks but took into account measures recently adopted by the government (some of which were taken after the court was petitioned and, in some cases, remained ineffective), as well as announcements and projections made by the government. The court concluded, in light of these elements, that the situation would clearly improve in the coming days and weeks.
A similar approach was adopted concerning the issue of screening tests, as the court also considered the expected results of measures taken by the government to increase testing capacities – while recognising that testing was limited for the time being because of the low availability of these tests – as well as, in the most recent ruling, the ongoing scientific research for new serological testing.
The French Administrative Supreme Court was petitioned with requests concerning the production and stocking of hydroxychloroquine and azithromycin, and the wider possibility for practitioners and hospitals to prescribe and administer these drugs outside the scope of their current marketing authorisation.(8)
These claims were based on highly publicised results presented by a French research team led by Professor Raoult, according to which the administration of these two drugs in the early stages of contamination would induce a surprising drop in viral load. The research concluded that patients appeared to be less contagious more rapidly and to present fewer symptoms.
In one case, the court was asked to order the state to request the National Agency for Medicines and Health Products Safety (ANSM) to regulate the use of hydroxychloroquine with a temporary recommendation for use, allowing its prescription without hospitalisation and for patients without respiratory distress.
Such a temporary recommendation for use allows practitioners to prescribe a medicinal product outside the therapeutic indications allowed in its marketing authorisation, whereas, in the absence of a temporary recommendation for use, prescription outside the scope of a marketing authorisation is possible only in the absence of an appropriate alternative medicinal product with a marketing authorisation or a temporary recommendation for use for the intended indication, and provided that the practitioner considers it essential, in the light of established scientific knowledge, to use this medicinal product to improve or stabilise a patient's clinical condition.
To deny these requests, the court referred to an opinion from the Public Health Council dated 23 March 2020 on COVID-19 management, which stated that the results of the study on which the claimants' requests were based to be considered with caution due to the low level of evidence. The court stated that further investigations were needed and, in light of current scientific knowledge, recommended a restrictive use of hydroxychloroquine and azithromycin, on a case-by-case basis.
The court also noted the ongoing European clinical trial ('Discovery') and that the current decrees allowed the prescription of hydroxychloroquine, initiated in healthcare facilities, under the prescriber's responsibility, in line with the Public Health Council's recommendation, which notably states that such prescription should be decided in a collegial manner, as soon as is practicable, to prevent the development of a severe form of the disease, which would require admission to intensive care.(9) The court concluded that, in the absence of established scientific knowledge, such measures were appropriate.
In two other cases, the court was asked on different grounds (namely, a petition for suspension and a petition for the protection of fundamental freedoms) to suspend part of the decree regulating the prescription and administration of hydroxychloroquine, which allegedly reserved the drug's use for the most advanced or serious cases, whereas scientific literature highlighted, on the contrary, that hydroxychloroquine was useful only at an early stage.
To dismiss the petition for suspension, the court – which can take into account in such proceedings only the facts available on the date of the petition – relied exclusively on the Public Health Council's opinion of 23 March 2020, cited by the petition, raising the fact that it recommended using hydroxychloroquine as soon as practicable, in order to prevent the development of a severe form of the disease, which would require admission to intensive care. The court also noted that the French Public Health Council considered that the decision on the use of hydroxychloroquine had to be made at the first stage requiring a hospitalisation.
In the petition regarding the protection of fundamental freedom, the court first held the same reasoning and then analysed the scientific data filed by the claimant in light of the facts available on the date of the ruling. The court noted the data's lack of scientific publications, its methodological limitations and the existence of a conflicting scientific study. The court also recalled ongoing studies and thus, once again, concluded that, in light of currently available scientific knowledge, no serious and clearly illegal failure could be characterised.
With this reasoning, the French Administrative Supreme Court attached great importance to the probative value of studies and the scientific evaluations of public health bodies in assessing the adequacy of measures adopted by government.
Concerning the question of production and stocks of hydroxychloroquine, the court noted that decrees of 25 and 26 March 2020 prohibited export by wholesale distributors and found that such measures were sufficient.
This contrasted with a recent case brought before the Guadeloupe Administrative Court, which was asked to order the regional health agency and the Guadeloupe teaching hospital to order the necessary doses of hydroxychloroquine and azithromycin to cover the existing and future needs of the local population, even if the treatment's effectiveness had not been established.(10) This request was notably motivated by Guadeloupe's location and sanitary conditions.
In this ruling, which raises questions on the reasoning adopted concerning the regional health agency's powers, the court applied the precautionary principle and granted the injunction sought.
However, this order was appealed and annulled by the French Administrative Supreme Court, which, in line with its abovementioned case law, refused to apply the precautionary principle in urgent summary proceedings on public health matters. Further, on 4 April 2020, while assessing Guadeloupe's specific situation and regulations which had been adopted for this territory, the court found that the regional health agency and the Guadeloupe teaching hospital decisions did not constitute a serious and clearly illegal failure of these public bodies.
Should the state's liability be assessed at a later stage in proceedings on the merits, the existence of a mere fault will be examined and need not be characterised as 'serious' or 'clearly illegal'. In this situation, the court may have to examine whether the adopted measures were cautious enough or, on the contrary, too cautious in light of the risks pending in adopting these measures (for instance, in the COVID-19 context, exposing a population to a drug's adverse events when its effectiveness has not been demonstrated).
In this regard, the measures adopted, as well as the French Administrative Supreme Court's rulings, could be viewed as a tentative move to exclude any future liability of the state.
However, the rulings leave open the question of the potential liability of practitioners in deciding to prescribe hydroxychloroquine in the COVID-19 context outside the scope of its marketing authorisation and the conditions set by the government, especially since, according to the court, current scientific knowledge is insufficient to determine whether the investigated treatment is appropriate. The COVID-19 context also raises the question of the potential liability of physicians who refuse to prescribe a therapy that proves to be effective in the future.
Although current legislation states that healthcare professionals cannot be held liable for damages resulting from the prescription or administration of a drug outside the scope of its marketing authorisation of a temporary authorisation for use, in case of serious health threat and in the current state of health emergency, it also specifies that the drug's prescription or administration has to be recommended or required by the minister of health or the prime minister.(11)
For further information on this topic please contact Armand Aviges, Cécile Panien-Ferouelle or Delphine Lapillonne at Altana by telephone (+33 0 1 79 97 93 00) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Altana website can be accessed at www.altanalaw.com.
(1) French Administrative Supreme Court, Order of 22 March 2020 (439674), Orders of 28 March 2020 (439693, 439726 and 439765), Orders of 4 April 2020 (439904 and 439905), Order of 6 April 2020 (439950) and Orders of 7 April 2020 (439806 and 439937).
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