Regulations hinder Africa's growth

In many African countries, a lack of harmonised technical requirements and capacity for medicines registration jeopardises timely access to essential medicines. Country-specific requirements impact negatively on registration of and access to medicines.

These were some of the findings of the survey undertaken by PIASA to assess the perceptions and experiences of pharmaceutical companies in South Africa with regard to the impact of regulatory requirements on registering, marketing and providing access to medicines in neighbouring African countries.

GMP inspection fees and country-specific labelling requirements were cited as key problems

According to Kirti Narsai, head of Scientific and Regulatory Affairs at PIASA, GMP inspections, GMP inspection fees and country-specific labelling requirements were cited as key problems. "Of the respondents, 89.5% indicated that country-specific requirements are problematic to implement," says Narsai. "In addition, 85.7% of companies indicated a decision not to market medicines in specific African countries - 71.4 % for commercial reasons, 57.1% because of registration costs, 42.9% because of retention costs and 42.9% because GMP inspection fees."

Approximately 50% of companies have discontinued supply in African countries for regulatory reasons and 85.7% of companies experienced interrupted supply because of regulatory issues.

Country-specific regulatory requirements are problematic

The African Medicines Registration Harmonisation Initiative (AMRHI) is an important body which has been created under the auspices of the WHO, the New Partnership for Africa's Development (NEPAD) and several donor organisations to assist African countries and regions to respond to the challenges posed by medicines registration - as an important, but neglected area of medicines access. AMRHI seeks to support African regional economic communities and countries in harmonising medicines registration and is seeking interested donors and other stakeholders that can help offer the requisite support. PIASA therefore supports the objectives of the AMRHI.

The survey concluded that country-specific regulatory requirements are problematic and impede market access of medicines. Recognition of international standards is important in countries with resource constraints and contributes to companies' ability to comply. Harmonisation should be preceded by interim agreements between regulators in Africa to facilitate medicine registration and access.

Over-regulation can be counter-productive

"PIASA believes that harmonisation will have a positive effect on medicines access and public health. The association recommends broad consultation with industry stakeholders and that interim agreements be expedited," commented Narsai.

Dr. Lembit Rago of the WHO believes that the time when all regulators could do everything themselves in isolation is over.
"Increasingly, regulators have to focus on activities that in their national settings give the most added value for promoting and protecting public health. Regulatory cooperation and harmonisation can help to direct the expert knowledge and limited resources to performance of the functions that can facilitate access to good-quality and safe essential medicines," he says.

(1) The PIASA study, Impact of Regulatory Requirements on Medicines Access in African Countries.