Veterinary Pharmaceuticals Regulation, International Relations Strategy for Agriculture: briefing
Agriculture, Land Reform and Rural Development
19 September 2006
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Meeting report
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 4th 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.
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