medical chronicle | march 2011 | page 11

piasa NEWs

The World Health Organization (WHO) has published on its website1 a study undertaken by the Pharmaceutical Industry Association of South

Africa (PIASA), highlighting the challenges of medicines registration in Africa. Against the background of increasing growth potential for pharmaceutical companies in developing countries, the study drills down to expose specific issues that are retarding progress.

In many African countries, a lack of harmonised technical requirements and capacity for medicines registration jeopardise 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 SA with regard to the impact of regulatory requirements on registering, marketing and providing access to medicines in neighbouring African countries.

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 of GMP inspection fees.”

Regulatory Challenges Limit African Growth

Thornhill Office ParkBuilding No 594 Bekker StreetVorna Valley, 1686South Africa

Tel: +27 11 805 5100Fax: +27 11 805 5105

Website: www.piasa.co.za

“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 said.Reference1. The PIASA study entitled ‘Impact of Regulatory

Requirements on Medicines Access in African Countries’ is available at http://apps.who.int/medicinedocs/en/m/abstract/Js17532en/

Country-

specific labelling

requirements

were cited as key

problems

Janssen’s Journey to Help Patients in Diepsloot

Janssen - a member of the Pharmaceutical In-dustry Association of South Africa (PIASA) -

is investing in the wellbeing of the Diepsloot community via its novel container counselling initiative, which offers residents access to mental health support services.

In February 2010, the South African Depression and Anxiety Group (SADAG) opened its first ever ‘container counselling’ service in Diepsloot; a community struggling with the ravaging effects of crime, unemployment, rape and HIV infection. Funded by Janssen, this new concept of ‘counselling in a container’ offers help and hope to residents of the Diepsloot community.

With a population of over 150 000, residents of Diepsloot previously had little - if any - access to mental health support and needed a friendly, affordable and easily accessible service.

SADAG and Janssen’s new counselling containers are equipped with computers, cell phones, desks, brochures and other information materials. The patient support material has been specially produced for this community.

Counsellors have established close working relationships with various groups in the

community in order to spread the word that support services are available. In addition to providing this much-needed counselling service, counsellors also fulfil an important educational function by visiting schools and raising awareness of mental health issues and ways to optimise mental wellbeing. Learners are also sensitised to the link between substance abuse and how it can trigger and exacerbate mental health conditions.

To enhance the impact of the container counselling initiative, SADAG has commenced with training potential support group leaders. These community members offer after-hours crisis assistance to residents.

The container counseling initiative has been welcomed by schools, clinics, police, non-governmental organisations and the community. This pilot project will hopefully evolve into a service that is available to many other communities.

The Janssen container counselling in Diepsloot reinforces the company’s commitment to investing in the community by ‘making mental health matter’ to residents in need of support.

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

The African Medicines Registration Harmonisation Initiative (AMRHI) is an important body that 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 medicine registration.

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 supports the objectives of the AMRHI.

The survey concluded that country-specific regulatory requirements are problematic and impede market access to 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.

In February 2010, SADAG opened its first ‘container counselling’ service in Diepsloot. Funded by Janssen, the container is fully equipped and provides Diepsloot residents with access to

much-needed mental health services. The Diepsloot community has embraced the initiative and it is hoped that this pilot project will soon be duplicated in other needy communities.

Benefits of harmonisation

Recognition of

international

standards is

important in

countries with

resource constraints

According to Kirti Narsai, head of Scientific and Regulatory Affairs at PIASA, Good Manufacturing Practise (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,” said Narsai. “In addition, 85.7%