The Ministry of Health has said it is planning to expand the National Drug Authority (NDA) mandate to include regulating food supplements in addition to drugs.
The disclosure was made by the Commissioner of Planning in the Ministry of Health, Dr Sarah Byakika, while addressing the just-concluded continental gathering of patients taking place in Entebbe.
“Before we start harmonising (drug regulations) at a national level, let’s talk about what’s taking place at the lower levels. We have the National Drug Authority (NDA) to ensure that the drugs are safe and utilised. NDA is to strengthen to look beyond drugs; we want to include food because we have realised that people are supplying unsafe food supplements,” Dr. Byakika revealed, stressing that there is an urgent need for regulation of food supplements.
Dr. Byakika was addressing patients from across Africa under their umbrella body, Uganda Alliance of Patients’ Organizations (UAPO), gathering in Entebbe, Uganda to discuss patient involvement in the upcoming plans for the African Medicines Agency (AMA).
Held under the theme: ‘Harmonisation for Patient-Centred Universal Health Coverage in Africa’ the two-day meeting at Imperial Botanical Beach Hotel, Entebbe, deliberated on ways of ensuring the patient voice is reflected in the Agency, which is due to be launched in 2018 as part of the of the African Medicines Regulatory Harmonization Initiative (AMRH).
The global umbrella organization, the International Alliance for Patients’ Organizations (IAPO) based in London, United Kingdom and the Uganda Alliance of Patients’ Organizations (UAPO), based in Uganda have embarked on the process of fostering patient involvement in the creation of AMA.
Kawaldip Sehmi, the Chief Executive Officer, IAPO, said: “Through interactive capacity building and knowledge-sharing sessions, IAPO and UAPO members and stakeholders will develop the tools to ensure that the patient movement across the region is made up of strong patient advocates.
“The goal will be to prepare patient advocates to take on the challenges and opportunities to arise from increasing regulatory harmonisation across Africa over the next few years.”
Joshua Wamboga, Chair-Elect, IAPO and Executive Director, UAPO, said: “Africa’s disease burden is finely balanced between infectious and non-communicable diseases, both of which require quality and safe medicines to address the pressing public health challenges faced by the region today and in the future.
“We believe that patient groups and patient advocates have an important role to play in developing and implementing strategies to meet these challenges. We hope to explore how all stakeholders can better work together to make this a reality.”
In 2009 the African Medicines Regulatory Harmonization (AMRH) Initiative was established to guarantee and accelerate regulatory harmonisation in the African continent. The founding actors, which include the WHO, the New Partnership for Africa’s Development (NEPAD), the Pan African Parliament, the African Regional Economic Communities and Organizations (RECs) and the national medicines regulatory authorities (NMRAs), concluded that “now is the right time to push for regulatory harmonisation in Africa.”
On resources, the AMRH says that 90 per cent of African NMRAs are incapable of guaranteeing quality, safety, and efficacy due to resource constraints. Because inefficient regulation can result in higher costs for medicines, patients in low and middle income countries are likely to particularly suffer from the lack of a harmonised strategy in medicines regulation.
According to the WHO and NEPAD, today there are more than 50 different NMRAs in Africa working independently to assess and authorise medicines.
These authorities rely on different procedures and have different standards in place, exhibiting a situation of structural fragmentation.