07 Aug 2013

The Assistant Minister of Health, Mr Gaotlhaetse Matlhabaphiri says the availability of skilled personnel, including pharmacists continues to be a challenge to the ministry.

He told Parliament on Tuesday that placing of local and external pharmacy adverts and increasing pharmacy training slots were some of the initiatives meant to address the shortage of pharmacists. In addition, he said, discussions were also ongoing on the establishment of a School of Pharmacy at the University of Botswana.

He also highlighted that the Drug Regulatory Unit had a total establishment of 16 of which, 12 were filled. “Taking into consideration the responsibilities of the Drug Regulatory Unit, we do recognise that there is need to increase this establishment, however, we are constrained by unavailability of posts,” he said. The assistant minister said the Medicines and Related Substances Act was passed into law by Parliament in March 2013. The law establishes a Semi-Autonomous Regulatory Authority, he added. Mr Matlhabaphiri said the ministry was in consultation with the Public Enterprises Evaluation and Privatisation Agency to assist with the transition of the Drug Regulatory Unit to an Authority.

He said between 2004 and 2013, 2490 applications were received and that there was a backlog of 1033 applications. He said 250 applications were not evaluated, 716 were in various stages of evaluation and 67 were deferred by the Drugs Advisory Board for more information and clarification from the applicants.

The assistant minister told MPs that with this backlog, the implications were that there was delay in registration which caused challenges with access to safe, effective and quality medicines. Registration, he said, was critical in ensuring that poor quality, counterfeit, substandard, falsified and falsely labelled medicines do not find their way into the country.

The minister said as for emergencies, the ministry was able to exempt medicines from registration top allow them to come in for patient use. He further said the Industrial Property Act was re-enacted in 2010 and made provision for voluntary licensing which allows for the minister of trade to issue licenses to a generic manufacturing company to make medicines for the country irrespective of the patent status of the medicines when needed to address public health needs.

He said this was in accordance with The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Mr Matlhabaphiri further said the Industrial Property Act also provides for parallel importation where the importation of unregistered medicines is allowed provided the medicines meet standard of quality, safety and efficacy.

He was responding to a question asked by MP for Ngwaketse West, Mr Mephato Reatile, who had wanted to know what was being done about the human resource issues in the Drug Regulatory Authority (DRA) and when it would become autonomous as per the World Health Organisation recommendation. MP Reatile also wanted the minister to state the current backlog of drug registrations and implications of that, as well as where Botswana is in terms of Intellectual Property Rights and access to medicines and whether there was any progress to amend legislation to address issues of public health. ENDS