Veterinary Pharmaceuticals Regulation, International Relations Strategy for Agriculture: briefing

AGRICULTURE AND LAND AFFAIRS PORTFOLIO COMMITTEE
19 September 2006
VETERINARY PHARMACEUTICALS REGULATION, INTERNATIONAL RELATIONS STRATEGY FOR AGRICULTURE: BRIEFING

Chairperson: Ms D Hlengethwa (ANC)

Documents handed out:
Department of Health presentation on veterinary pharmaceuticals
Department of Agriculture presentation on veterinary pharmaceuticals
Department of Agriculture presentation on international relations
Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
Medicines and Related Substances Control Act 101 of 1965

SUMMARY
Members met with the Departments of Agriculture and Land Affairs and Health to receive briefings on veterinary pharmaceuticals, the registration of medicines and the international relations strategy of the Department of Agriculture and Land Affairs. Act 36 of 1947 dealt with stock remedies. The Medicines and Related Substances Control Act included a definition of veterinary medicines. The legislation sought to define the registration process of veterinary products. A Stock Remedies policy was being developed. The role of the Medicines Control Council was explained. Registration requirements in terms of Act 101 were outlined. The International Relations Strategy would seek to promote international trade. Regional food security was a priority. Various international initiatives were in place. The 4^th World Congress on Rural Women would be held in Durban in 2007.

MINUTES
Veterinary Pharmaceuticals presentation by Department of Agriculture
Dr Ernest Mokantla (Registrar of Act 36 of 1947) explained the areas of agriculture included in Act 36 of 1947. The Act dealt with farm feeds, sterilizing plants, fertilizer and stock remedies. Act 101 of 1965 included a definition of veterinary medicines. Examples were anaesthetics, narcotics and certain antibiotics. The Department of Agriculture was represented in various Department of Health committees such as the Clinical Committee and Scheduling. The Veterinary Products Policy Committee sought to harmonise the registration processes of veterinary products. The Agricultural Production Enhancement Agents (APEA) Bill was completed in 2003 and submitted to the Minister. However, it was returned due to a policy vacuum. A Stock Remedies policy was currently being developed. A memorandum of understanding would be developed between the Departments of Health and Agriculture and Land Affairs to drive the production of regulations and implementation. 

Department of Health presentation
Ms Mandisa Hela (Registrar of Act 101 of 1965) explained the mandate of the Department in safeguarding national health and ensuring access to medicines that met approved standards of safety, quality and efficacy. The Medicines Control Council would be strengthened and registration of practitioners controlled. The MCC was mandated to approve clinical trials and inspect manufacturing premises. The MCC had to ensure public safety, public protection and risk assessment amongst others. The pillars of medicine regulation were explained. The World Health Organisation elements of effective regulation were adhered to. Veterinary pharmaceuticals had been regulated in South Africa since 1947 under Act 36. Act 101 included veterinary medicines due to safety concerns. Registration requirements in terms of Act 101 were explained. The definition of veterinary medicine and stock remedy were mentioned in both Acts. All animal medicines had potential safety concerns in humans. Inappropriate use of antibiotics in animals could result in antimicrobial resistance.

Department of Agriculture International Relations presentation
Ms Vangile Titi (Deputy Director General: Sector Services and Partnerships) explained the objectives of the International Relations Strategy. Bilateral relations were an important component of the strategy. Increased international trade would be fostered and sufficient levels of human resource development and technical assistance provided. Consolidation of the African agenda was an important priority. Interventions in Africa would occur in support of Nepad. A forum involving the Department and agri-businesses had been established. Engagement would occur with the Southern Africa Development Community. The regional food security situation would be reviewed. Various initiatives were underway involving Brazil, India and South Africa including biofuels, livestock development and technical matters. Co-operation would also be maintained with certain European Union countries. The reform of the global governance system would be promoted. The Maputo Declaration would be communicated to all stakeholders including governments, relevant ministries, parliaments, civil society and the private sector. The fourth World Congress on Rural Women would be held in Durban in 2007.

Discussion
Mr D Dlali (ANC) sought clarity on the policy vacuum with regard to the APEA Bill. African traditional medicines had been in use for a long period and could not be regarded as a new development. He asked what monitoring mechanisms were in place to evaluate the implementation of amendments. The communication between the two departments of Health and Agriculture had to be improved. He noted that the Sudan was still mired in a costly and violent conflict and therefore post-conflict reconstruction appeared incongruous. The lack of interest by South Africans in SADC Secretariat positions due to poor salary levels was problematic. A greater sense of duty had to be instilled in bureaucrats. The reference to the "10% budget" in the National Medium Term Investment Programme was a common refrain. More attention should be focused on implementation.

Ms M Nkompe-Ngwenya (ANC) asserted that information dissemination on animal vaccinations and diseases had to be communicated in a more effective manner. She asked what mechanisms were in place to enhance communication practices. Timeframes on the Memorandum of Understanding between the two departments in question had to be specified.

Mr J Bici (UDP) asked whether the need existed to amend Act 36 of 1947 and how far the process had progressed. He referred to the recent Jerusalem Declaration regarding the subsidisation of seeds and fertilizers and asked which seeds were included in South Africa.

Dr A Van Niekerk (DA) referred to the ongoing and lengthy feud between medical practitioners and veterinarians and said that the two groups would have to co-operate in future. Veterinary research had outperformed medical research in the 1950s. The Department of Health dominated the research field at this juncture. Veterinarians tended to be ignored. The combined strategy from the two departments had to be explained. The current impression was that little interaction between the Departments of Health and Agriculture and Land Affairs occurred. The registration of animal medicines was an on-going debate. Veterinarians had to be represented on the Scheduling Committee. He asked what steps would be taken to rectify the situation.

Mr S Abram (ANC) noted that the policy vacuum with regard to the APEA Bill was a long-term problem. The policy had been developed in 2003. The problem could not be regarded as a current problem. He suggested that the stakeholders were working in “silos”. The National Veterinary Drug Policy draft had been handed to the Director-General in 2002. Therefore claims of a policy vacuum were false. He asked when last the two Acts had been amended and the extent of the amendments. He asked whether the Department made regular inputs to the South African Animal Health Association (SAAHA). Research and veterinary capacity was inadequate. For example, one state veterinarian was appointed to serve the entire ostrich-farming region that consisted of 900 farmers.

Ms B Ntuli (ANC) said that Members had to ensure proper implementation of programmes through meaningful oversight. Poverty had to be reduced in the SADC region. She asked what support was provided to farmers. Institutional restructuring had to be accompanied by adequate levels of funding. Poverty and underdevelopment initiatives only focused on seed and fertilizer subsidies. Efforts had to be expanded to other areas. A concise implementation strategy was required to improve living conditions.

Mr Diale asked whether improvements had been made in food security as rural areas remained a priority.

Ms H Blose (ANC) asked whether Department bursaries for veterinary students were allocated to would-be scholars. Graduates should be employed immediately to gain valuable experience. She asked whether grassroots women would be included in the planned Congress of Rural Women.

Ms R Rathebe (Director: Safety and Quality Assurance) responded that the Minister had decided at the time in 2003 that the policy on the APEA Bill was not appropriate. Act 36 covered many different subjects. Four different policy documents had been drafted pertaining to Act 36. A workshop to discuss the pesticide policy would be held on 26 September 2006. Pesticides and fertilizers would be dealt with concurrently. Act 36 was an important piece of legislation that required amendment.  

Dr Mokantla agreed that sufficient levels of information did not reach the target audience. The Department had undertaken a legislative review in 2005 to determine the impact of legislation on the ground. Consultation with stakeholders was a priority. A promotion strategy for information had been developed to improve levels of dissemination. The Department participated in agricultural shows and distributed information pamphlets. Inspectors were located in provinces and interacted with provincial governments. Act 36 would be made available electronically on the Department website.  Communication with other key roleplayers in the implementation process would be enhanced. Service level agreements and memorandums of understanding would also be established with stakeholders. The communication programme of action would be formulated by both departments. Quarterly meetings would be held with the SAAHA. The Department of Agriculture and Land Affairs had put in place a Directorate of Education and Training to address lack of capacity amongst veterinarians.

Ms Hela stated that the monitoring strategy involved regular feedback from tertiary institutions where relevant medical research was conducted. A committee on traditional medicines was a new development in terms of traditional medicine. A veterinary committee of Council consisted of 14 veterinarians to represent their interests and a veterinarian sat on the Scheduling Committee. The department maintained representation on the Scheduling Committee. Co-operation did occur between the relevant departments.

Ms Titi stated that a presentation would be arranged for Members on the National Medium Term Investment Programme. Food security packages had been included in various agricultural support programmes. Regional farmer support included extending land under irrigation, trade promotion and the rehabilitation of over-used farmland. Research activities focused on livestock, forestry and fisheries. R140 million had been provided to the World Food Programme to support food security. The report on the status of food security related to production data rather than access issues. Bursaries were provided to would-be students. Students had to first complete a BSc before gaining access into the veterinary sciences course. Many of the recipients of bursaries failed to gain admittance to veterinary science schools. Discussions would be held with various tertiary institutions. The Department sought to monitor the progress of students. The department would strive to include the voice of rural women in conferences and other endeavours.

Ms Rathebe responded that the department had no research capacity but focused on registration based on scientific data provided. Officials evaluated information as opposed to testing its validity. A written response on the certification of farms to engage in certain farming activities would be provided. The responsibility rested with the Directorate-Animal Health. A response would also be provided in due course on the National Veterinary Drug Policy.

Committee minutes
Committee minutes of the 22 August and 5 September 2006 were adopted.
 
The meeting was adjourned.