Mass Njie- Ndow

BY: MASS NDOW-NJIE

__________

A. Introduction

On 05 October 2022, the World Health Organization (‘WHO’) issued a medical product alert which referred to four cough syrups found in The Gambia which failed to meet “either their quality standards or specifications” (‘the Cough Syrups’). The alert further explained that samples of the Cough Syrups had been analysed and that they contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.” The alert continued by emphasising the severity of the risks associated with consumption of the Cough Syrups:

  • Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
  • Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.” [Original emphasis]

Unfortunately, before it was known that the Cough Syrups were toxic, they had already been consumed by various children across The Gambia (‘the Incident’). The news outlet, Al Jazeera has reported that by 01 August 2022, 28 children had died after taking one of the Cough Syrups. The death toll has more than doubled since then and on 08 October 2022, it was announced that 69 children had died after taking one of the Cough Syrups. However, unfortunately, it is expected that the death toll will continue to increase.

The BBC has reported that the police in The Gambia have commenced an investigation. While criminal liability may arise in consequence to the Incident, criminal liability will not be explored within this opinion.

Instead, this opinion seeks to consider the merits of a potential class-action civil case which could be brought on behalf of (a) the deceased; and (b) their families and (c) those that have consumed one of the Cough Syrups and endured pain, suffering or loss of amenity in consequence (but did not suffer fatal consequences).

Many people are understandably upset and confused as to how it was possible that toxic medications were able to find their way to consumers in The Gambia. Consequently, criticisms have been lodged in various directions. In conducting initial research (including reviewing posts on social media platforms), the author has seen criticisms being aimed at the (a) producer of the Cough Syrups; and (b) the importer of the Cough Syrups; and (c) the Government of The Gambia; and (d) the WHO. For the purposes of this opinion, each of them will be treated as a potential Defendant. This opinion will now go on to explore the merits of a potential case against each of them (under the laws of The Gambia), in turn.

  • B. The merits of a case against the Producer, Pharmacy, or Importer

The Producer of the Cough Syrups has been identified as Maiden Pharmaceuticals Ltd. (‘the Producer’) which is a company based in New Delhi, India.

Various news outlets including the likes of Al Jazeera and Reuters have reported that the importer of the Cough Syrups is a US based company named  Atlantic Pharmaceuticals Inc. However, the author understands from a reliable source that the importer of the Cough Syrups was in fact a company based in The Gambia with the same name, namely, Atlantic Pharmaceuticals Ltd (‘the Importer’). 

Furthermore, a press release from the State House in The Gambia dated 08 October 2022 stated the following:

  • “President Barrow has authorised the Medicine Control Agency, through the Ministry of Health, to suspend the license of the suspected pharmacy and importer”

It is not entirely clear at this stage whether the pharmacy and the Importer referred to above is the same entity or if they are two different entities. However, this is immaterial to my ultimate opinion and so this is not explored any further.

  • The Law

S. 6 of The Gambia Consumer Protection Act 2014 (‘CPA 2014’) provides consumers in The Gambia with the right to safe, good quality goods which are suitable for the purposes for which they are generally intended.

Under s.29(2) of the CPA 2014, various parties are held jointly liable for injury or loss caused by goods supplied to consumers. This states the following:

  • “(2) Producers, importers, dealers, suppliers, providers and all persons involved in the distribution chain shall be jointly liable under civil law, for indemnities deriving from injury or loss caused by the goods supplied or services rendered so long as the person who suffered the damage makes the request in a reasonable time after damage occurs.” [Emphasis added]

Defences may be available to relevant parties in specified circumstances. S. 32 of the CPA 2014 sets out these circumstances as follows:

  • “32. Defences
  • (1) A supplier may have a defense against liability under the Act if it can be proved that-
  • (a) The action complained against was-
  • (i) a mistake;
  • (ii) due to reliance on informing from another source
  • (iii) the act or default of another person
  • (iv) accidental; or
  • (v) caused by some other cause beyond control” [sic]
  • Analysis

S.32(1)(a)(ii) appears to contain a typo. It is my view that this was likely intended to state ‘due to reliance on information from another source’. If this is correct, one might expect that in any civil action brought against the pharmacy or the Importer, they may seek to argue that they relied upon information from the Producer as to the contents of the Cough Syrups.

If the pharmacy or the Importer sought to deploy this argument, they would be likely to suggest that it was reasonable for them to believe that the Producer had provided them with medications which complied with quality standards and/or the specifications outlined on the box of the medications themselves. The argument would follow that it would be unreasonable to expect them to open each and every box of medication that is imported into The Gambia and test it before any dispensing takes place. If a court were to accept such arguments, any claims alleging negligence against the pharmacy or the Importer would also be likely to fail for the same reasons.

On the other hand, if information came to light which suggested that the pharmacy or the Importer had reason to know (or ought to have known) about the condition of the Cough Syrups before they imported or sold them, then of course, the above-mentioned defence would not be open to them. Furthermore, in those circumstances, a claim in negligence would likely be successful, even if a claim under the CPA 2014 was not.

In my view, the argument that the pharmacy and/or the Importer relied upon information from another source carries merit and on balance this defence would likely be accepted by a court in The Gambia. Thus, there is a real prospect that the pharmacy and the Importer would have a defence against any civil claim made against them in The Gambia.

If the pharmacy and the Importer were able to rely upon the above-mentioned defence, this would leave the Producer of the Cough Syrups as the only party with potential liability under s.29 of the CPA 2014. The only defence which appears arguable from the perspective of the Producer is that their actions in producing a toxic product amounted to a “mistake”.

The term “mistake” is not defined within the CPA 2014, but nonetheless it is my view that it is unlikely that the Producer would be able to rely upon this defence. Regardless of what “mistake” means in the context of the CPA 2014, it is highly unlikely that the drafters of the CPA 2014 intended for this particular defence to apply in circumstances where there have been serious errors which could also constitute negligence. If that were the case, potential defendants could always argue (in most or all cases) that their actions constituted a mistake. In turn, the CPA 2014 would effectively become redundant as potential defendants could never be held accountable. That could not have been the intention of the drafters, and I would expect a court in The Gambia to agree with this view.

Thus, it is my view that there is strong case against the Producer of the Cough Syrups for breaching the CPA 2014. Furthermore, it could alternatively be argued that the Producer was negligent in producing the Cough Syrups in a manner which did not comply with its specification and I would also expect a case pleaded in this way to be successful.

C. The merits of a case against the government of The Gambia

The Medicines Control Agency (‘the Agency’) is established by the Medicines and Related Product Act 2014 (‘MRPA 2014’). Amongst its other functions, the Agency is given the function of regulating “all matters relating to efficacy, quality and safety of medicines and related products”. Thus, the importation of medicines into The Gambia falls within their remit.

Any civil action aimed in the government’s direction would inevitably need to be brought against a particular government department or government agency. Given the Agency’s functions relating to the importation of medicines into The Gambia, it is logical that any civil action aimed against the government of The Gambia would need to be directed specifically against the Agency. Thus, this section analyses a potential civil case against the Agency.

Criticisms have been directed against the Agency questioning how they permitted the Cough Medicines to be imported into the country when they were unsafe for consumption. Firstly, questions have been raised as to whether the Agency’s rules and processes were sufficiently fit for purpose. Secondly, questions have been raised as to whether the relevant rules and processes in place were complied with.

  • The Law
  • Limitation on who can be granted import licenses or permits

S. 36(3) of the MRPA 2014, states that the Agency “shall grant import licence or permit to only licensed pharmaceutical companies” [sic]. Thus, it is clear that under this Act, the Agency are limited in what companies they are able to grant import licenses or import permits to.

Further, Reg. 20(2) of the Medicines and Related Products Regulations 2020 (‘MRPR 2020′) explains:

  • “(2) A person shall not import any medicine and related product into The Gambia unless he or she is issued with a permit by the Agency and shall submit –
  • a completed application form obtained from the Agency;
  • a copy of his or her identity document;
  • a certificate of professional registration for practice where applicable;
  • a certificate of incorporation and an operational license where applicable; and
  • one original and one copy of the certificates of analysis for each batch to be imported or a Certificate of Pharmaceutical Product issued by the regulatory authority of the exporting country” [sic]

Consequently, Reg. 20(2) of the MRPR 2020 implies that before granting permission to import medicine into the country, the Agency must be provided with the above-outlined documents by the relevant pharmaceutical company. Crucially, this includes “a certificate of analysis for each batch” of medicine being imported or a “Certificate of Pharmaceutical Product issued by the regulatory authority of the exporting country”.

  • Registration requirements

S. 26(1) of the MRPA 2014 provides that “A person shall not […] import […] a medicine or related product unless the article has been registered by the Agency.” Accordingly, it is clear that the registration of medicines is an essential part of the importation process.

However, the registration of a medicine does not occur automatically. Under Reg. 43(1) of the MRPR 2020, “A person who intends to register a medicine or related product shall apply to the Agency”.

Reg. 43(2) goes onto provide further detail about what is required when making an application to the Agency to register a medicine. This provides (inter alia) that an application shall include “data on the safety, efficacy and quality of the medicine or related product” and “samples of the medicine”.

  • Enforcement powers of the Agency

Under Reg. 68 of the MRPR 2020, the Agency is afforded powers to seize or quarantine relevant medications in a wide-ranging set of circumstances. These circumstances include (inter alia) if the medication is “substandard and falsified”, “has expired” or “has been declared unfit for use or consumption”. Furthermore, under Reg. 69, the Agency is also afforded powers to take a “sample of a medicine […] for analysis.”

These wide-ranging powers are discretionary, and the provisions do not use mandatory language. Instead, the Agency “may” exercise such powers but the Agency is not necessarily required to do so.

  • Restriction of liability

Reg. 87(1) of the MRPR 2020 is headed “Restriction of Liability” and states the following:

  • “(1) The Agency, the Board, a Committee member or staff of the Agency shall not be liable for any loss or damage arising from any decision made or carried out in good faith in the exercise of powers or performance of functions under the Act and these Regulations.”

At first glance, this passage seems to indicate that the Agency is essentially immune from civil proceedings. However, taking another glance at Reg. 87(2) brings and end to such thoughts. This states:

  • “(2) The Agency, the Board, a Committee member or staff of the Agency shall be liable for any loss or damage if the loss or damage is due to wilful misconduct, gross negligence or failure to comply with the Act and these Regulations.” [Emphasis added]

Following a review of this provision, it is clear that the Agency could be a defendant in a potential civil claim in the circumstances emphasised above. These circumstances will now be explored in turn.

  • Analysis
  • “Wilful misconduct” or “gross negligence”

If the Agency were aware (or ought to have been aware) that the Cough medicines were toxic (before they were given to consumers), then it could be suggested that an omission to exercise any of their enforcement powers constituted either “Wilful misconduct” or “gross negligence”.

Proving wilful misconduct would need to show that the omission was intentional and so this is likely to be more difficult to prove. But, proving gross negligence in such circumstances is likely to be easier and achievable.

Gross negligence is not defined in the relevant Act or Regulations. However, in the UK case of Wilson -v- Brett (1843) 11 M&W 113, it was suggested that there is no difference between negligence and gross negligence and that gross negligence is merely negligence “with the addition of a vituperative epithet”.

In any event, even if ‘gross negligence’ is something greater than ‘negligence’, I do not consider that it would be likely to make any difference. If it transpired (a) that the Agency knew (or ought to have known) that the Cough Syrups were toxic before they were given to consumers; and (b) did not exercise any of their powers to prevent consumers from taking the Cough Syrups, then it is arguable that this was an irrational omission and constituted the most serious type of negligence. 

There is no information before me which suggests that the Agency were aware of any such information. However, investigations are ongoing and new information could come to light which suggested otherwise.

  • “Failure to comply with the Act and these Regulations”

It would be arguable that the Agency had failed to act in accordance with the MRPA 2014 and the MRPR 2020 if it became apparent that the Agency had granted an import licence or import permit:

    • to a person or company that is not a registered pharmaceutical company; and/or
    • to a person or company who did not submit all of the documents outlined in Reg. 20(2) of the MRPR 2020.

Consequently, in those circumstances, the Agency could potentially be liable for loss or damage in a civil action if that person or company then used their import licence to import a defective product.

In the instant case, I am unaware whether or not the Importer is a registered pharmaceutical company and I do not have any knowledge of the documents that they submitted (or failed to submit) before being granted an import license. But, given the name of the Importer (Atlantic Pharmaceuticals), I would expect them to be a registered pharmaceutical company. Nonetheless, if it transpires that the Importer was not a registered pharmaceutical company or that they did not provide all of the necessary documents outlined in Reg. 20(2) of the MRPR 2020, then it could be argued that the Agency failed to comply with these regulations when issuing the Importer with a license. In those circumstances, a civil case could be advanced against the Agency.

Furthermore, if the Agency registered the Cough Syrups without testing a sample of them first, then it is also arguable that this constitutes a failure to act in accordance with the MRPR 2020. In particular, Reg. 43 of the MRPR 2020 requires a sample of any medicine to be provided to the Agency before that medicine can be registered and imported into the country. Obtaining a sample of a medicine would only be valuable if the intention was to test that sample. If not, the exercise of obtaining the sample would serve no purpose at all and the drafters of the MRPR 2020 would not have included it. In that context, if no testing of the Cough Syrups was carried out by the Agency, then there could be a strong argument that the Agency has failed to act in accordance with its obligations under the MRPR 2020. Consequently, this could also result in the Agency being liable for loss or damage in any civil action brought against them.

I cannot definitively state whether or not any testing of samples was carried out by the Agency in relation to samples of the Cough Syrups. However, the available information suggests that this was not likely to have been done. A press release from the Office of the President dated 14 October 2022 provided an insight into why such testing may not have been carried out. The press release explained that there were “thousands of unregistered products in the country” due to the “lack of testing facilities in The Gambia and the exorbitant cost involved in outsourcing testing.” Additionally, the BBC have reported that the executive director of the Agency has explained that they “prioritise checks on anti-malarial drugs, antibiotics and painkillers, rather than cough syrup.”

If a court agreed that there was a mandatory requirement imposed on the Agency to test samples of medications before registering those medications, then the explanations provided in the preceding paragraph would not provide any sort of defence for the Agency. The question for the court would not be focused on resources at all. Instead, the question would simply be: did the Agency fail to test samples of the Cough Syrups? If the answer to that question is yes, then in my view, there is a plausible case against the Agency which would be likely to succeed. 

D. The merits of a case against the World Health Organisation

According to the WHO’s website, the WHO Prequalification of Medicines Programme is a service provided by the WHO “to assess the quality, safety and efficacy of medicinal products”. Accordingly, questions have been raised around whether this programme has failed to fulfil its purpose and whether such a failure contributed to the Incident. The argument which follows these questions is that the WHO may have been negligent in its implementation of the programme, thus enabling the Cough Syrups to be given to consumers. If this could be proven, is there a viable civil claim against the WHO?

  • The Law

The Constitution of the WHO suggests that the organisation is to enjoy immunities from legal proceedings. Article 67 (a) of the Constitution of the WHO provides:

  • “(a) The Organization shall enjoy in the territory of each Member such privileges and immunities as may be necessary for the fulfilment of its objective and for the exercise of its functions.

Furthermore, Article 68 of the Constitution of the WHO explains how such immunities shall be defined:

  • “Such legal capacity, privileges and immunities shall be defined in a separate agreement to be prepared by the Organization in consultation with the Secretary-General of the United Nations and concluded between the Members.”

The separate agreement referred to in the preceding paragraph later became the Convention on the Privileges and Immunities of Specialized Agencies. Under Art. III of this international convention, the specialised agencies (which include the WHO) shall “enjoy immunity from every legal process except in so far as in any particular case they have expressly waived their immunity”. The Gambia provided its notification of succession relating to this convention on 01 August 1966 and therefore, The Gambia is bound by its provisions.

The question of whether the WHO can be sued for negligence has also been tested recently in the USA. In King et al -v- The World Health Organisation (S.D.N.Y 2021), a United States District Court dismissed a claim brought against the WHO alleging that the organisation was negligent in responding to the Covid-19 pandemic. The dismissal was justified on the grounds of the WHO’s immunity which is guaranteed in the above-mentioned legal instruments.

  • Analysis

As a result of the WHO’s well recognised immunity from legal processes, there would not be a viable claim against the WHO relating to the Incident unless the WHO voluntarily chose to waive their immunity. The WHO has never waived immunity in the past and there is nothing to suggest that they may change their approach in the future. Thus, any potential claims against the WHO can be swiftly ruled out without necessarily going into the detail of what their precise failings may have been.

E. Conclusion

Section B of this opinion has analysed the potential case against the relevant Producer, Pharmacy and the Importer of the Cough Syrups. I consider that a civil action brought against the Producer of the Cough Syrups would have strong prospects of success. However, even if a successful claim were brought against the Producer, a question arises around whether any subsequent judgment is likely to be enforceable or not. If not, then consideration may need to be given as to whether it would be possible and worthwhile to bring proceedings in India.

Whether or not it is possible and desirable to bring a claim in India is beyond the scope of this opinion. This opinion is instead focussed on the application of the laws of The Gambia. Yet, the focus of this opinion should not be understood as implying that The Gambia is the most convenient or appropriate forum for any claims to be brought.

Section C of this opinion has also analysed the circumstances in which a claim against the Agency is likely to be successful. Most prominently, it is my view that a claim against the Agency would be likely to succeed if it transpires that the Agency failed to test samples of the Cough Syrups before they were registered and imported into The Gambia. A press release from the Office of the President as well as reported comments from the Agency’s executive director implies that the Agency did not test samples of the Cough Syrups. If I am right about this, then there is likely to be strong prospects of success in any claim brought against the Agency. 

There is not sufficient information currently before me to suggest that a case against any other parties would be likely to succeed under the laws of The Gambia. However, investigations are ongoing and new information is still coming to light. It is in that context that throughout this opinion, I have indicated the kinds of information which could come to light in the future, which may indicate that there is also a plausible case against another party.

Inevitably, this opinion has not been able to cover every scenario that could arise in the future, and therefore, the contents of this opinion may need to be revised as new information comes to light.

If you have any questions about this opinion or are interested in instructing me on any legal matters, please do not hesitate to contact the civil clerks at my Chambers. They can be contacted at: civilclerks@7br.co.uk

MASS NDOW-NJIE

Barrister, 7BR Chambers

London, United Kingdom

31 October 2022

LEAVE A REPLY

Please enter your comment!
Please enter your name here