IMANI is one of the biggest champions of Noguchi and their valiant efforts to develop local biomedical research capacity.
When the story of how Ghana survived COVID-19 comes to be told, the sacrifices of dozens of scientists, technologists and administrators working at the Noguchi Memorial Institute of Medical Research (“Noguchi”) to ensure that Ghana’s testing capacity could rise to the occasion notwithstanding resource limitations would certainly receive pride of place.
We are thus surprised at the brewing “civil war” among scientists in that fine institution about the institution’s bizarre relationship/non-relationship with an entity incorporated on June 3rd, 2020 (registration number: CS079792020) by name “Frontiers Healthcare Services”. Itself owned by a labyrinthine maze of companies in Ghana and beneficially controlled from the notorious tax haven of the Island of Dominica.
We have received worrying complaints from Noguchi scientists and others urging us to “publicise their grievances” over this matter as they cannot do so themselves for fear of retribution.
Ordinarily, IMANI is not a vent for random grievances.
However, the documents we have seen about this matter raise serious public policy issues of a very alarming nature. It is important that a public conversation be had because there are aspects of the situation, we have been reliably informed, that are simply above the administrative capacity of Noguchi to handle internally. In the circumstances, we decided that our best contribution to helping resolve the festering impasse was to go public and shine some sanitising light on the situation.
On August 27th, 2020, a few days before the President reopened the borders, a Dr. Emmanuel Acquaye wrote to Dr. William Ampofo, Head of Virology at Noguchi, requesting that he validates the “standard operating procedures” for a “COVID-19 antigen detection” mechanism described as “novel, and the first of its kind worldwide”.
Our contacts at Noguchi are furious that Noguchi’s resources were used for this process off-site without any payment and auditing trails. They insist that research students from Noguchi were involved in process calibration work without any proper agreement between Noguchi and Frontiers Healthcare to warrant such an arrangement.
This comes at a time where agitation over conditions of service are at an all-time high in Noguchi and budgetary provisions for capital investment are failing to keep up with what the institution requires to preserve its enviable position in research.
More alarmingly, our sources are adamant that a “globally novel” biomedical intervention, as the Frontiers Healthcare product has been billed, cannot be used on humans without the approval of the Ethical Review authorities at the institution. And yet, the Department of Virology has gone ahead to work with Frontiers Healthcare without any institutional review. What is going on here?
Let us make it very clear that we support public-private partnership models for securing critical resources for our prized research institutions. We wholeheartedly encourage the likes of Noguchi to enter into such commercial arrangements to boost their income and range.
In fact, our only reason for getting involved in this matter is because, here, it appears that a great opportunity for a mutually rewarding PPP is being abused. This raises two questions: why is Noguchi not benefitting from the millions of dollars Frontier Healthcare Services is generating from offering commercial biomedical services by drawing on Noguchi’s expertise, and why is Noguchi facilitating a process that is so far defying basic biomedical ethics and even national laws?
The Health Institutions & Facilities Act of 2011 (Act 829) is very clear about the prerequisite for delivering clinical and bio-medical laboratory services in this country: a company and its facilities have to be licensed by HEFRA – the Health Facilities Regulatory Agency of Ghana.
Our checks reveal that at the time that Professor Ampofo oversaw the supposed validation processes for Frontiers Healthcare to begin making money, these approvals had not been secured. As we understand the situation, moonlighting personnel from Noguchi have continued to sustain the Frontiers Healthcare operation.
Frontiers Healthcare furthermore did not have the personnel and other prerequisites that would have allowed HEFRA approvals anyway. The fact that it was operating an FDA-certified medical device would not, per our checks, be sufficient in this regard, since the overall protocols, personnel and health & safety regime goes beyond medical device certification.
IMANI strongly advocates as follows:
- Noguchi immediately begins to take steps to regularise the relationship between its Department of Virology and Frontiers Healthcare Services, so that the institution itself benefits directly for the use of its personnel and expertise in this biomedical collaboration, however styled;
- Proper ethical approvals and regulatory licensing be pursued immediately to ensure that the activities of Frontier Healthcare Services are brought in line with the proper regime of excellence that Noguchi’s local and international partners expect of it.
- HEFRA, the Ministry of Health and Noguchi individually and jointly tell Ghanaians, beginning with their own staff, what informed the exemptions to standard policy under which a 3-month old company is being allowed to operate licensed and regulated services, whilst regulators continue to harass longstanding, law-abiding, companies in the health sector for far minor infractions.