4th Feb 2018

Source: Kaieteur News

In a scathing ruling issued on January 30, 2018, Chief Justice (ag) Roxane George, S.C. deemed Food and Drugs Director, Marlan Cole’s refusal to grant registration of several life-saving drugs to Dr. Balwant Singh’s Hospital, arbitrary, capricious and unlawful, making a previous order nisi being granted absolute.

Balwant Singh’s Hospital, through attorney Devindra Kissoon, filed an application to quash Cole’s refusal to issue an import licence for 18 lifesaving drugs. The application was also to compel the regulator to reconsider those licence applications and for him to provide a list of all new drugs currently being sold in Guyana along with the names of those persons authorised to sell those drugs.

Cole, according to court documents filed by the hospital last August, refused to register the drugs.

The director, the court documents said, indicated he would not register any drugs manufactured in India. He had also initially failed to provide the hospital with the requested list of drugs.

Cole had also rejected all attempts by the hospital to settle the matter without court intervention. Kissoon, a leading commercial lawyer and founding partner of London House Chambers, argued that Cole’s failure to approve the licences or provide the applicant (the hospital) with the list, created an untenable situation. This is because as a major public health provider, it is unable to import drugs necessary for the treatment of its patients.

Worse yet, by its refusal of a list that may be available for sale by licensed importers, the Food and Drug Analyst endangered the well-being of its patients and the applicant’s business operation.

Kissoon argued that the hospital had routinely been provided with lists in the past and issued licences for drugs manufactured in India pursuant to Section 78(2)(k)(v) of the Food and Drug Regulations.

Cole argued that the Food and Drug Administration entered into a Memorandum of Understanding (MoU) with Caribbean Public Health Agency (CARPHA) which implemented a new Caribbean Regulatory System in Guyana, and since those drugs for which applications were submitted were not registered with CARPHA, licences could not be issued.

Cole also argued that he was concerned about consumer safety and stated that he had provided the hospital with the requested list of drugs.

However, in response, Kissoon argued that Cole was deliberately misleading the Court, stating that “list supplied by Mr. Cole is woefully incomplete, in not containing the name of the local suppliers, registration numbers, date of registration, and manufacturer of the registered drugs.”

Kissoon argued that without knowing where to buy lifesaving drugs, the hospital’s patients were at risk.

He gave the example of Naloxone, an opioid antagonist which is used to save the lives of babies who are born with little or no vitals.

Kissoon argued that “to be unable to know where to obtain that drug in Guyana is simply absurd”.

He insisted that this information was routinely provided to the hospital in the past.
The lawyer argued that the CARPHA MOU did not repeal Section 78(2)(k)(v) of the Act, and had no bearing on the matters before the Court. In fact, the MOU stated that it was non-binding.

Kissoon demonstrated to the court not only that the  drugs sought, to be registered manufactured by two of India’s largest and well established pharmaceutical companies (Bharat Serums and VHB Medisciences Limited, and Merck Serono, a multinational company established in 1668 and headquartered in Germany focused on bio pharmaceuticals), but all of the applications contained evidence of safety to human beings and evidence that certification was issued only after documentation was produced about bio availability, bio equivalence and stability.

Kissoon argued that “the Applicant is simply applying for registration of drugs that have already been developed and approved in other various countries. Clinical trials of these drugs have already been completed and approved in the development stage, which may take up to 12 to 15 years for development.

“The applicant is not trying to register experimental drugs or any drug which has not been approved for human use, nor is there any evidence of this in the defence.”
The hospital also alleged that the “respondent continues to arbitrarily and capriciously apply the applicable laws differently to different importers, effectively discriminating against Dr. Balwant Singh’s Hospital.

For example, as evidenced in the attached report published by the Public Procurement Commission in August 2017, the respondent allowed Ansa McAl to import drugs without satisfying the requirements of the applicable laws.”

The Chief Justice (ag) sided with Kissoon, making the orders previously granted absolute, deciding that there has been no repeal of Section 78(2)(k)(v)  and that the CARPHA MOU could not and does not repeal that regulation.

She held that the hospital not only had a legitimate expectation to a licence, but to deny the licence was unlawful. The Court stated that there was no evidence of danger to human life and that the requested lists complete with the requested information must be provided, since the list is a publication within the public’s interest.

She stated that Cole acted unlawfully, unreasonably and capriciously, awarded $200,000 in costs, and ordered compliance within 60 days.

In recent times, there have been accusations of abuse of authority against Cole by not only medicine importers, but food and drinks suppliers.

Kaieteur News was told that the list is “being eagerly awaited” as it would indicate the extent of abuse by the FDA.

Comments are closed.