By Erica Penfold*
South Africa has been facing an ongoing crisis of running out of essential drugs, such as anti-retrovirals for HIV patients. This highlights the need for a regional response to the provision and procurement of pharmaceutical drugs.
A recent survey attests to the reality that medicine shortages in South Africa require urgent attention. But it is not the only country experiencing stockouts. The challenge is being faced by a number of other southern African states too, including Zambia and Malawi.
The challenge could be addressed by a regional focus on provision and procurement. In the longer term, the development of medicines in the region should also be considered.
A regional approach is being explored by the Union of South American Nations. A regional framework for access to essential medicines has been adopted by World Health Organisation members in the Western Pacific and has seen positive results.
The region has launched a price information exchange index and a regional partnership project in pharmaceutical policies. This allows for regional exchange of information on products and collaboration on policies. Southern Africa has started a similar process but nothing has come of this as yet.
What’s standing in the way of a regional approach
The reality is that regulatory barriers and a lack of awareness about the need to create an effective regional policy are all barriers to facilitating a more effective approach.
Pharmaceutical policies and provisions are currently managed by national health departments. A pharmaceutical business plan has been developed by the health sector of the Southern Africa Development Community (SADC) Secretariat to address regional access to drugs. Poor supply chain management and stocks continuing to be managed nationally have hindered its progression.
A possible solution could be for the SADC Secretariat to extend the plan by providing continued regional support. A number of trade barriers would need to be overcome first. These include:
- a plethora of national pharmaceutical policies;
- a difficult import permit regime;
- the existence of multiple drug regulatory authorities with conflicting policies; and
- restrictions imposed by the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement on drug access.
Strong support for regional approach
There is evidence of strong support for regional regulatory capacity for pharmaceuticals. These initiatives include the:
- African Medicines Registration Harmonisation Initiative, which provides support for harmonising regulations;
- the SADC Medicine Regulatory Authority Forum; and
- the SADC Pharmaceutical Business Plan, although this has not been renewed since its expiry in 2013.
These three initiatives could change how medicines are distributed and accessed throughout the region.
A good start would be if states, the regional secretariat and the Troika – made up of states elected to lead the SADC summit – worked together. They could start by creating greater awareness about the need to co-ordinate access to pharmaceuticals within countries as well as across regional boundaries.
The role of big pharma companies
The monopoly on pharmaceuticals by big pharma companies, including Aspen, Pfizer and Bayer, continues to stand in the way of governments attempting to regulate distribution. There is a distinct need for leadership and co-ordination of the sector. Evidence suggests that pharmaceutical companies collaborate with multilateral organisations and other health initiatives without the involvement of national governments or regional bodies.
Given the irregularities experienced from a bottom up national approach, the solution may well lie in a regional position. Importantly, SADC has a regional integration mandate. But its secretariat only has powers to co-ordinate, facilitate and assist implementation.
In addition, the secretariat relies on a limited number of staff making monitoring and evaluation difficult. The social development directorate is responsible for co-ordinating cross-border HIV and malaria initiatives, but this only applies if medicines are supplied by national government.
An additional challenge is the movement of people across borders. Considering the stockout problem for South Africa, for example, the additional burden of migrants needing medication causes further complications. The need for regional access to health care is clear, but co-ordination challenges have proven to be too large for member states to manage.
Attempts to harmonise policies in the region have not had great success. This is clear from continued stockouts at national level. Further evidence of failure is a rise in the use of nyaope, a highly addictive drug containing antiretrovirals that is increasingly being used in poor communities, particularly in South Africa.
There is an urgent need to establish regulatory procedures across the region. The stockout problems cannot continue unabated. Citizens’ lives are at stake. Pharmaceutical regulation must become a regional body priority, in partnership with multilateral organisations, to create a better quality of life for citizens.
*Erica Penfold is the Researcher/Project co-ordinator at the Poverty Reduction and Regional Integration project at SAIIA. This article was first published in the Conversation. It was also published by Business Day.