The Herald’s investigation into the Accra High Court’s order for the Food and Drugs Authority (FDA) to pay a colossal amount of GH¢94 million to Tobinco Pharmaceuticals Ltd for the unlawful destruction of unexpired drugs belonging to the company, is unearthing lots of dirt with allegations of collusion.
The paper’s findings are that, the FDA is simply on its way to paying a dubious judgment debt, it should have fought with the arsenals at its disposal, including documents authored by the Chief Executive Officer (CEO) of the institution, Mimi Delese Darko.
Additionally, The Herald discovers that, although the issues Tobinco, led by Samuel Amo Tobbin, complained of happened in 2013 during the Dr Stephn Kwabena Opuni administration at FDA, he rather went to court in 2019, six clear years under the current Delese Darko administration and after Nudu Mogtari.
Interestingly, Mr Tobbin, who has had various brushes with the FDA’s strict regulations, including the importation and distribution of Oxytocin used to induce labour or strengthen uterine contractions, or to control bleeding after childbirth, sought damages and interest on medicines confiscated from Tobbin Pharmaceuticals starting from 2015 during the tenure of Nudu Mogtari, who replaced Dr Opuni.
Remarkably, Delese Darko, who took over from Mogtari and had also been at the FDA long before Dr Opuni and Alhaji Mogtari, did not defend the institution’s actions.
Neither was Opuni and Mogtari subpoenaed by Justin Agbeli Amenuvor, FDA’s private lawyer, to give evidence in favour of the FDA to save the state from the GH¢93,905,760.79 million payment.
Strangely, the judgement suggested the FDA, called only one witness, without giving his or her name, but said that during cross-examination the witness “admitted that merely because a consumer experienced adverse effects from taking medications, it does not make the drug fake”.
It is not clear, whether the various departmental heads some of whom are still in the employment of FDA, and had taken part in the confiscation exercise of Tobinco’s unregistered drugs were in court to give evidence in favour of the state. Neither was it clear from the judgement that, the owners of Bliss GVS Pharma Limited, gave evidence in support of Tobinco.
However, in a bizarre twist to the matter, The Herald, has sighted excerpts of a document prepared by Delese Darko which revealed the confessions of Mr Tobbin when he was summoned to the FDA headquarters for questioning on the importation of “unregistered Artesunate/Amodiaquine suppositories into the country”.
A copy of the CEO’s document in the custody of The Herald said that “On the 10th September, 2013 an invitation for a meeting at the FDA Head Office on the issues was extended to the Chief Executive Officer of the Company, Mr Tobin which he honoured.
“In the meeting with the Head of Drug Enforcement Department, Mr Tobin admitted importing the unregistered Artesunate/Amodiaquine suppositories into the country.
“He also admitted that most of the products imported by the Company, had expired registration, whilst others were never registered with the FDA.
“He, however, explained that the Management of Tobinco Pharmaceuticals, had decided to manufacture all the imported products locally at Entrance Pharmaceuticals, a sister local pharmaceutical manufacturing company which was still under construction, but was optimistic will soon be ready for production, hence the reason for holding on with the registration of the products.
“Mr Tobbin, was tasked to recall all the Artesunate/ Amodiaquine suppositories in the country and to initiate registration process for the unregistered products”.
The Herald’s contact at the FDA, revealed that so bad was Tobinco’s products that he was forced to ship back his unregistered and unwholesome products back to the country of origin.
This paper further learnt that, FDA got tired of destroying the unwholesome drugs and also feared polluting the environment with poisonous gases coming from the destruction of Tobinco’s medicines that it insisted on the shipment.
Furthermore, The Herald’s contact at the National Security Secretariat also known as “Blue Gate” or “Castle Annex” also revealed meetings that went on between Tobinco pharmaceutical officials led by Mr Tobbin, the CEO of Bliss GVS Pharma Limited, S.N Kamath and the FDA officials, where additional confessions were made by Mr Tobbin.
The meeting at the National Security Secretariat, was presided over by the late Kweku Duah Dankwa, who was a deputy to Lt. Col Larry Gbevlo-Lartey.
The Herald information is that on September 2, 2013, a request was made by then Acting Deputy Chief Executive in charge of Safety Monitoring and Clinical Trials, Delese Darko, now FDA CEOto the Drug Enforcement Unit to carry out investigations on Tobbinco’s drugs.
Mrs Darko, wanted the FDA to verify whether the unregistered product Artesunate/Amodiaquine, was being promoted and distributed by the Plaintiff, Tobinco Pharmaceuticals.
Mrs. Darko, also wanted FDA to verify whether the unregistered products were being prescribed by Doctors at the Kwesimintim Hospital.
This was following a report received from a Pharmacist at Kraspect Pharmacy.
The report of Drug Evaluation and Registration (DER) dated September 6, 2013, showed that out of 103 products in total, 48 were unregistered, 36 out of the 103, had expired registration and 16 were pending registration. Only 2 had valid registration.
It is unclear, if this critical information was provided to the court, especially as it was under the direct mandate of the current CEO.
A serialized media report had claimed that in 2014, the FDA confiscated pharmaceutical products imported to Ghana by Tobinco on the grounds that the products were unwholesome.
In 2019, Tobinco sued FDA and asked the court to award cost against the FDA and declare its action as unlawful.
Tobinco, the plaintiff judgement creditor in the suit was represented by Mr Philip Addison, of Addison Bright Sloane, Barristers, Solicitors, Consultants, Accra.
In reaching a decision, the court presided over by Justice Audrey Kocuvie-Tay, declared that the wanton destruction of Tobinco’s unexpired products without obtaining any order from the court was unlawful.
The court again declared that “the unlawful lockup of Tobinco’s warehouses by the FDA and bad media publicity by the FDA resulted in the massive expiration of Tobinco’s products between June 2014 and August 2015.”
Justice Kocuvie-Tay, further declared that the order by the FDA prohibiting the sale of Tobinco’s products without obtaining an Executive Instrument from the Minister of Health was unlawful.
She declared that the actions of the FDA and its CEO in banning Bliss GVS Pharma Limited from importing drugs into Ghana without the issuance of an Executive Instrument (E.I.) by the minister were unlawful.
The judge held that that Tobinco, did not import fake drugs into the Ghanaian market.
She declared that the unlawful conduct of the FDA and its CEO, caused substantial damage and loss to the business of Tobinco.
The court said that the actions of the FDA in declining to register Tobinco’s drugs, confiscation of Tobinco’s drugs from customers, order for the arrest of Tobinco’s CEO and detention of Tobinco’s imported drugs at the Tema Port was an abuse of the FDA’s statutory powers and duties.
For these actions by the FDA which occasioned losses to Tobinco, the court ordered the FDA to pay special damage of GH¢24,003,157.20, being the total cost of Tobinco’s products which expired in warehouses.
The court also ordered for special damages in the sum of GH¢511,414.35, being the cost of expenses incurred by the plaintiff for demurrage.
It also ordered for special damages in the sum GH¢67,300, being the cost of expenses incurred in respect of bonded warehouses and for the payment of interest on the amounts stated above at the prevailing bank rates.
The court said that even though Tobinco, did not indicate the commencement dates of the calculation of interests on the various amounts granted supra, evidence proffered gave an indication of the dates of the occurrence of the infractions and/ or losses as indicated against the amounts/reliefs granted as follows: GH¢24,003,157.20 from January 2015, at the prevailing bank rate till date of final payment, and GH¢511,414.35 from November 2015, at the prevailing bank rate till date of final payment.
The court awarded as cost of GH¢67,300 from January 2015 at the prevailing bank rate till the date of final payment in addition to general damages of GH¢5 million against the FDA for misfeasance. The court further awarded a cost of GH¢1 million against the FDA in favour of Tobinco.
The others, include recovery of special damages in the amounts GH¢24,003,157.20, GH¢511,414.35 and GH¢67,300.
Tobinco, wanted US$147, 572.52, as the total cost of goods manufactured by the company which were detained and subsequently destroyed by the FDA.
GH¢511,414.35, for demurrage and GH¢67,300, for Bonded warehouse.
More to come!
