The East African Community (EAC) has agreed to set up a Medicines Registration Harmonization (MRH) project to address issues related to improving supply of medicines and harmonizing medicines registration in the region.
The USD 12.5m project. which was launched recently, is expected to be implemented over a period of five years.
The project, said to be a key contributor to public health, would lead to access to good quality, safe and effective medicines.
It will see all the five partner states of Uganda, Rwanda, Burundi, Kenya and Tanzania have a single law regulating the registration of medicines in the region.
Speaking at the project launch in Arusha, chairperson of the EAC Council of Ministers Musa Sirma from Kenya said lack of access to essential medicines remained one of the most challenging regional problems.
The EAC partner states, he said, had limited capacity to ensure efficient supply of medicines to health units due to lack of standardized and harmonized procedures in the pharmaceutical sector which created uncertainty.
“As a result the availability of drugs remains a challenge, and this project aims at addressing issues related to improving the production and supply of medicines in the region,” he said in a speech availed to EANA.
He added that the project would enable all the manufacturers of medicines to operate at minimum acceptable standards in all the countries.
This would boost production and supply to the wider market since all standards will be similar and the regulatory framework would also attract movement of professionals which is good for business development, according to Sirma.
EAC Secretary General Dr. Richard Sezibera noted that the total investment in the pharmaceutical sector in the region was estimated at USD 800m.
“But intra-trade in medicines in the region stands at USD 265m while only 30 per cent of total demand for medicines in the region is met by the local investors,” he said.
“This means that 70 per cent of the medicines are imported and this is one of the reasons why the EAC industrialization policy lays emphasis on the promotion of the pharmaceutical sector,” he added.
Dr. Sezibera pointed out that the project would help build capacity for the private sector, establish regulatory authority in Burundi and strengthen Rwanda’s authority and harmonization of regulatory framework, some of which will be translated into national laws.
Ugandan State Minister for Health Dr. Richard Nduhura appealed to all the five partner states to scale up harmonization of all the laws and legislation, not only in health but across all sectors.
He said harmonization of all the laws in the EAC region would save Uganda from being used as a hub for counterfeit products.
He said Uganda, being at almost the centre of the region, was the hub of all products that are being exported or imported into the countries of the Great Lakes region including the EAC partner states.
“Uganda is therefore a hub of all products from the region, including pharmaceutical products, but harmonization of laws and regulations in the region would save the country from being used as a hub for counterfeit products,” he said at the launch.
Kenya’s Permanent Secretary in the Ministry of Health Mark Bor said the country was strongly committed to the project as its objective was targeted towards priority diseases.
Kenya and UNIDO, he explained, carried out a survey that had indicated that some local industries in the health sector have not achieved international standards, so this project is a “welcome milestone.”
He added that the Kenyan government was also reviewing health laws, especially the pharmaceutical sector, to align it with the regional standards.
“We are not working in isolation; we need an integrated approach and this would help our manufacturers in the region who still experience problems to adopt international standards,” he said.
Rwanda’s Minister of Health Dr. Agnes Binagwaho noted that launching of the project was a great opportunity for Rwanda since the country is still developing the science and technology sector.
“It will help in the provision of high quality medicines at affordable prices and on time,” he said.