Patients from across Africa are gathering together today in Entebbe, Uganda to discuss patient involvement in the upcoming plans for the African Medicines Agency (AMA).
Across two days, patient advocates and a range of stakeholders will be exploring 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.
This process is beginning at the meeting: ‘Harmonisation for Patient-Centred Universal Health Coverage in Africa’. The meeting, which is being held at Imperial Botanical Beach Hotel, Entebbe, Uganda on 4th-5th, July 2017, will bring together IAPO members, patient representatives and a range of stakeholders from over ten different countries across Africa.
Patients are well aware that no significant results can be achieved by patient advocates alone. This has to be a multi-stakeholder approach that draws on strong relations with a range of actors. This needs to include representatives such as the African Union, its member countries, policy-makers, the pharmaceutical industry and intergovernmental bodies, including the World Health Organization. Only by coming together can we make tangible progress towards patient-centred universal health coverage.
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.”
Across the two-day workshop, the meeting will explore how patients can become key actors in the AMA, and how we can advocate for sustainable patient engagement in the African harmonization plans.
Delegates will discuss what is needed for patient representatives to be strong partners in the development of the AMA and what they need from the founding stakeholders in return, to form strong and mutually beneficial partnerships.
Joshua Wamboga, Chair-Elect, IAPO and Executive Director, UAPO, said: “Today 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 includes 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, determining a situation of structural fragmentation. As can be seen from the AMHR’s figure below, the current scenario can be placed at the far left hand of the “harmonisation ladder”, where every country abides by “its own technical requirements” for medicine registrations.
Currently there is insufficient clarity around the time needed to process an application and arrive at a decision. This lack of clarity places itself within a more general context in which little transparency is in place both “before” and “during the registration process”. The WHO maintains that a more “harmonised” environment would create the conditions for a better understanding of “registration processes” by all stakeholders.
Today, there is a worrying lack of strategic vision of the role that patients and patient representative could play in a more harmonised regulatory environment. Yet the ongoing conversation of how to set up a more standardised, harmonic, and efficient regulatory process in Africa provides an unprecedented opportunity. This is the possibility for healthcare stakeholders to work together and shape rules, policies and procedures in such a way so as to render the harmonization process better reflective of the stakeholders’ needs and values in the Region.