Pfizer Inc has reached agreement with the Kano State government in Nigeria to settle Kano State's claims arising from the 1996 Trovan clinical study, which was conducted during Nigeria's worst meningitis epidemic in history.
Under the terms of the settlement, Kano State will dismiss both the civil and criminal Trovan-related cases it filed against the company and various individuals, and Pfizer specifically denies any wrongdoing or liability in connection with the 1996 study. The company has said all along that the 1996 study was conducted with the approval of the Nigerian government and the consent of the participants' parents or guardians, and was consistent with Nigerian laws.
"We have been a partner with the people and governments of Nigeria for more than 50 years. The company believes that a mutually agreeable resolution to the Trovan cases is the best way to continue that relationship and allow Pfizer and the Nigerian governments to focus on what matters - improving healthcare for all Nigerians," said Pfizer senior vice president and associate general counsel Brad Lerman.
Under the terms of the settlement with Kano State, Pfizer has agreed to establish a Healthcare/Meningitis Fund from which study participants can receive financial support; underwrite several healthcare initiatives chosen by the Kano State government that benefit the people of Kano State, totalling US$30 million over a period of two years; and reimburse Kano State for US$10 million in legal costs associated with the litigation. The Healthcare/Meningitis Fund will be available to all individuals who meet the qualification criteria necessary to verify their participation in the 1996 Trovan clinical study. The Fund will be administered by an independent six-member Board of Trustees, with three members each chosen by Pfizer and the Kano State government. The Board will make the final determinations on eligibility and levels of financial support. The maximum amount that could be disbursed by the Fund is US$35 million, but the final amount will depend on the total number of valid claims submitted.
Kano State and Pfizer will name a separate six-member board to oversee the $30 million allocated to support health initiatives designated by Kano State.
"We are especially pleased that the benefits of this settlement will be directed first and foremost to those who contracted meningitis in 1996 and also participated in the clinical study at that time," Lerman said. "With the procedures in place for the Healthcare/Meningitis Fund, the people of Nigeria will have confidence that the parties have taken strong steps to ensure that the funds reach only those for whom they are intended."
The settlement's healthcare initiatives build on Pfizer's work in Nigeria for more than 50 years. In August 1957, Pfizer became the first US pharmaceutical company to establish operations in Nigeria. Since that time, the company has contributed to the well-being of Nigerians by providing quality medicines, creating jobs, developing local expertise, and bringing foreign investment and innovative healthcare solutions to the country. Nigeria is a part of Pfizer's presence in Africa, and the company looks forward to its continued health partnership with the governments and people of Nigeria.
Today, the company participates in and supports several initiatives in partnership with the government, the private health sector and nongovernmental organizations that benefit the health of the Nigerian people and the country's healthcare system. For instance, Pfizer routinely conducts disease awareness campaigns through public education programs. Pfizer also invests in developing local health expertise through health education and good clinical practice workshops. Lastly, Pfizer is working in partnership with the Nigerian National Agency for Food and Drug Administration to prevent the entry of counterfeit drugs in Nigeria by improving regulations and strengthening judicial enforcement.
The cerebrospinal meningitis epidemic that struck Nigeria in 1996 took at least 12,000 lives over a six-month period, and affected more than 100,000 people. The results of Pfizer's clinical study showed that Trovan helped save lives and was at least as effective as the best treatment available at Kano's Infectious Disease Hospital.