One of Rwanda’s representatives in the East African Legislative Assembly is pushing for a bill entitled the ‘East African Community Pharmaceuticals Bill’ to promote access to essential medicines and facilitate the promotion and development of the local pharmaceutical industry.
The rationale, MP Francine Rutazana told The New Times on Tuesday, is “to help the EAC have a regional body and legislation which will guide the coordination and harmonisation of national legislation for more results in terms of local production.”
Before tabling a motion seeking leave to introduce the Bill she explained that, among others, “the concern” is that the bloc has not established favourable policies for local producers or adequately promoted them to be able to meet the pharmaceutical needs of the region and compete with imported drugs.
She also noted that there are still discrepancies in the registration procedures for essential medicines provided for by the national health policies and regulations of the partner states.
Rutazana is concerned that reliable access to affordable and quality-assured medicines in East Africa remains a huge challenge since most medicines in the Community are still paid for directly by citizens through out-of-pocket payments.
She is convinced that it is necessary for the six EAC countries to improve the management of pharmaceuticals in the bloc to ensure access to affordable, quality essential medicines, including those for the treatment of various priority communicable and non-communicable diseases.
“All Partner States heavily rely on pharmaceutical imports, especially for branded and innovator products and the inability of local pharmaceutical industry to sufficiently meet local demands for low-cost generic production and pharmaceutical innovation has allowed foreign companies to strongly dominate the pharmaceuticals market,” Rutazana said.
According to her, domestically produced medicines have less than 20 per cent of the value of the pharmaceutical market in the six-member bloc.
“One of the ways by which the Community can improve both the availability of essential medicines and their quality is to promote and support local production of essential medicines required by the Community,” she said.
The EAC, now home to more than 170 million citizens, produces less than 30 per cent of the medicines it needs.
In April last year, a 10-year strategic plan for pharmaceutical manufacturing was launched.
At the time, Kenya was reported to have the largest pharmaceutical market in the bloc, with some $740 million, followed by Uganda, at $450 million, then Tanzania $400 million, Rwanda $ 100 million and Burundi $75 million.
The market share of imports in Africa is estimated to be over 70 per cent, with a market share of generics estimated at 62 per cent in Kenya and other partner states.
In EAC, more than 50 per cent of pharmaceuticals imported into the region come from Asia, particularly from India and China.
In 2017, the Council of Ministers adopted the regional pharmaceutical manufacturing plan of action 2017 – 2027.
It has several strategies and priority areas for the region’s pharmaceutical sector including establishing a regional roadmap for local manufacturers to upgrade and attain internationally recognized quality standards, as well as introducing and implementing incentive packages and appropriate financing schemes for local pharmaceutical manufacturers.
It also involves establishing a regional framework for mutual recognition of harmonized medicines registration and good manufacturing practices (GMP) inspections.
The GMPs are practices required in order to conform to the guidelines recommended by agencies that control the authorisation and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
Under Article 118 of the EAC Treaty, EAC countries committed to, among others, develop a common drug policy which would include establishing quality control capacities and good procurement practices; and harmonise drug registration procedures to achieve good control of pharmaceutical standards without obstructing movement of pharmaceutical products within the region.