Health Minister, Kwaku Agyeman-Manu

Attorney General, Godfred Dame, says some clauses in the Health Ministry’s $64 million contract with Dubai based businessman, Sheikh Mahktoum, to supply Sputnik vaccines to Ghana, are biased and skewed against government.

He also says, some of the provisions are in breach of the Food and Drugs Authority’s regulations.

In a letter dated April 12, 2021, to the Health Minister, Kwaku Agyemang Manu, the Attorney General urged the Ministry to buy vaccines directly from Russia because other countries are doing that.

Chief Director at the Health Ministry, Kwabena Boadu Oku–Afari had written to the Attorney General’s Office on 10th March 2021, requesting that the Attorney General’s review of the contract between the Ministry and the private office of Sheikh Ahmed Dalmook Al Maktoum for the supply of 3.4 million doses of the Russia Sputnik vaccines.

Godfred Dame’s reply to the Health Minister, first of all observed, that the Ministry had already signed the contract before submitting it for review. He also noted, that, the agreement is an international one and must go to Parliament for approval, to ensure validity.

The Attorney General also observed, that clause 7.1 of the contract, which places liability to recall vaccines in case of unsatisfactory side effects, on the Health Ministry, is in conflict with the regulations of the Food and Drugs Authority. Clause 7.1 of the agreement says, “the liability of the seller of any action which is outside its reasonable control is excluded.”

The Attorney General says, “we note per the FDA pharmacovigilance regulations, a manufacturer, seller, or distributor must recall vaccines if asked to do so by the FDA Ghana due to any unsatisfactory side effects. The clause above seems to be in conflict with the regulations of the FDA Ghana.

“We further note that the clause is ambiguous, vague and skewed against the buyer. It is thus suggested that the agreement be amended to classify what the parties mean by “outside reasonable control” and the same provided for the buyer.”

The agreement also says the Ministry of Health shall not withhold payment for any supplied doses of the vaccines over alleged defects unless written notice has been given to the seller. The Attorney General observes this clause is biased against Ghana.

“The agreement says the buyer shall not be entitled to withhold or defer the whole or any part of any payment due for the delivered vaccine of any alleged defect, dispute, cross-claim or lien or any other claim whatsoever against the seller unless written notice has been given of the same in accordance with this schedule and such claim is recognized in writing by the seller and the seller agrees to such retention in writing signed by its authorized representative.”

“We note that Clause 1(A) is biased against the Buyer. It is suggested that the clause be amended to allow the buyer to return any batch of vaccines once there is a defect and the buyer brings it to the notice of the seller…” the Attorney General wrote.

The agreement says the Ministry of Health shall not initiate or undertake any batch recall of the vaccines without the prior consultation with and written agreement of the seller.

The AG says the clause places Ghana “at the mercy of the seller because the seller will have to agree before the buyer can initiate or undertake such recall,” and suggested amendments.

The Attorney General observed that the distributor in the agreement indicates that it is not an agent of the manufacturer and therefore will not be liable for any losses under this agreement suffered by the buyer or any person whatsoever.

The AG suggested it will be more prudent for the Ministry to engage directly with the manufacturer who can be held liable in case of adverse effects for the procurement of the next batch.

The AG also observed the agreement had no specified duration or term of expiration and suggested amendments.

The Attorney General also raised concern with the designation of the London Court of International in Dubai International Financial Center as the location for dispute resolution.

“We note that the venue of the arbitration which is Dubai, is not a neutral ground for the parties,” the AG said. The AG suggested London rather be made the ground for dispute resolution.

The Attorney General reiterated its call on government to ensure it procures the vaccines directly from Russia and not use middlemen.

“We also note that the vaccines are produced or manufactured from Russia and other countries are procuring directly from the manufacturers.

But Ghana has elected to procure it through a third party who is not an agent of the manufacturer, as such, making him not liable to Ghana and Ghanaians in the likely event of adverse effect.”

“We suggest that the republic of Ghana buys directly from the manufacturers instead of procuring through an individual in Dubai.

“Our suggestion is premised on the fact that, the vaccine being new, when there arise any issues in relation to side effects, the manufacturer is better placed to respond to and resolve matters than the individual from whom the procurement is being made,” the letter reads.

The Attorney General observed it will be difficult to hold the businessman liable for any defects arising out of the use of the vaccine.

“Our research indicates that it is the policy of the regulators, in this case, the FDA to register manufacturers and distributors of vaccines and to require them to have and operate an office locally or within the territory so that when withdrawals become necessary, the notices are issued directly to the manufacturers and distributors.

“In this case, the liability will be on the government in the absence of the seller in this agreement having a physical office in the territory since it is the government that is procuring and giving the vaccines to the public.”

The Attorney General further advised that the Procurement Act, as amended must be complied with.

The AG also cautioned that the contract raises possible data protection law breaches. Referencing Clause 6.2 of the agreement, the AG said the buyer shall within one to three days from the date of receipt of notice or information by the Health Ministry, concerning any adverse effect relating to any vaccine and in accordance with the applicable law of the territory, notify the seller of such adverse effect.

The notice shall be forwarded by email to the designated point of contact and include the name, address and telephone number of the person making the complaint or report of an adverse event, as well as the vaccines involved, the nature of the adverse effect and such information as the seller may reasonably require.

The Attorney General warns “there could be potential data protection breaches with clause 6.2.”

Quoting section 20 of the Data Protection Act, the AG said a person shall not process the personal data of anyone without the prior consent of the data subject.

“It is suggested that the Ministry of Health liaises with the Data Protection Commission to confirm whether or not sharing such requested data with third parties will not result in a breach of the data protection rights of people since the Ministry is dealing with the private office of Sheikh Ahmed Dalmook Al Mahktoum.”

Parliament in early July, set up a 9-member committee to probe the Sputnik vaccines contract following concerns the average $19 it costs, is far higher than the ex-factory price of $10.5.

The businessman eventually supplied only 20,000 doses of the vaccines but could not deliver on the rest until the June deadline for delivery expired.

Mr Agyemang Manu told the committee the agreement was terminated by Sheikh Mahktoum on July 14, 2021, a day before the Parliamentary Committee investigating the deal, began its hearing.