African governments must invest in Clinical Trials - Dr Kaluwa

Dr Owen Laws Kaluwa, Representative of the World Health Organisation (WHO) in Ghana, has asked African governments to increase investments in research and development of new medicines, especially in the conduct of clinical trials.

He said investments in the development of new products was not at a fast enough pace to keep up with the need for new diagnostic and other products to deal with health issues on the continent.

He made the statements at the Assembly of the African Vaccine Regulatory Forum (AVAREF), held in Accra, on Wednesday, on the theme: “Regulatory Preparedness and Response for Resilience for Health Systems”.

Dr Kaluwa said African governments and actors must, especially, focus on working on products for diseases that disproportionately affected Africa.

He noted that two major challenges in the development of new products were the scarcity of research into new products needed to deal with the diseases in Africa; and the long time it took to complete the processes for approval of clinical trials.

He explained that the processes involved in the approval was so long that by the time an efficacious medicine or vaccine was developed for a disease, a lot of time had been spent in the process.

The focus thus, he noted, should be how to advocate for more resources to do more work in finding new tools and how to speed up approvals of the research or trials that had to take place to identify efficacious medicines.

“The need to have systems to speed up the approval of new products is important, the need for oversight is very important, and that will help to move forward and be prepared to deal with many diseases and challenges that we face in the health sector…,” Dr Kaluwa said.

He said the countries must take ownership, by allocating more resources to clinical trial sites and regulatory authorities, and also improving governance and transparency by ensuring the compulsory registration of all clinical trials in the region prior to authorisation in the Pan-African Clinical Trial Registry or any WHO-primary registry.

“Investments in ethics committees and NRAs and effective management of trial sites will permit development and implementation of new, safe and more effective health products to address national priorities,” he noted.

Dr. Afisah Zakaria, Chief Director of the Ministry of Health, host of the conference, commended the WHO for convening the AVAREF Assembly and the African Union Commission and the NEPAD Planning and coordinating agency for jointly organising the fifth African Medicines Regulatory Authorities Conference, which follows the AVAREF Assembly tomorrow.

Speaking on behalf of the Minister of Health, she noted that quality-assured, safe and effective medicines, vaccines and medical devices, including in-vitro diagnostics, were fundamental to a functioning health system; thus the need to strengthen regulatory systems to provide good quality, safe, and efficacious products for optimum health care response.

She also stressed the need for capacity building of regulatory agencies, as the absence of adequate numbers and technical capacity of such agencies where they existed, had contributed to the incidence of sub-standard or falsified medical products on African markets.

“There is the need to build the capacity of staff working in regulation of medical products and provide them with the needed logistics and remuneration to undertake their mandate without fear or favour,” she stated.

AVAREF is a network of national regulatory authorities and ethics committees of African countries, convened by the WHO, as a platform to build ethics and regulatory capacity and to promote the harmonisation of practices in support of oversight of clinical trials in the region.

Its proposed goal is to build the capacities of National Regulatory Authorities (NRAs) and Ethics Committees robustly, as well as those of Regional Economic Communities to ensure efficient, transparent, high quality and timely clinical trials, and licensing of medicines and vaccines critical to improved maternal, family and general health in Africa.