Nevirapine registration: briefing by Medicines Control Council

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16 August 2002
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Meeting report


16 August 2002

Chair: Ngculu, Lincoln Vumile

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Briefing by Medicines Control Council on registration of nevirapine
Nevirapine registration

Representatives of the Medicines Control Council (MCC) briefed the committee on issues related to the recent political and scientific debates surrounding the registration of the HIV antiretroviral agent nevirapine (NVP). Dr Precious Matsuso, Dr T.M. Mathivha, and Dr Jonathan Levin represented the MCC, presenting an overview of the agency's history, the controversy surrounding nevirapine (NVP) registration, and assessment of the South African SAINT Study. Members of the committee focused on MCC independence from political pressures, the reasons for the ongoing NVP review, and other aspects of the NVP debate.

Briefing by Medicines Control Council on registration of nevirapine
Representatives of the Medicines Control Council presented three related briefings to the committee.

Dr T.M. Mathivha introduced the MCC, presented an overview of its history, and described the factors involved in its registration of medicines. Please refer to the briefing notes attached for the details of Dr. Mathivha's presentation.

Dr Precious Matsuso discussed some of the relevant issues surrounding the registration of NVP in South Africa. Please refer to the briefing notes attached for the details of Dr. Matsuso's presentation.

Dr Jonathan Levin focused on the controversial SAINT Study that followed the 2000 Durban AIDS conference. Please refer to the briefing notes attached for the details of Dr Levin's presentation.

Questions and Discussion
Mr Ngculu opened the meeting to questions and discussion.

Ms Baloyi (ANC) asked why the MCC had ordered a review of NVP if the medicine was not banned, noting that the decision had a not inconsiderable impact on the public, and especially the welfare of those with HIV/AIDS.

Ms Baloyi asked how the MCC could register drugs but not monitor compliance with instructions regarding proper use or trace adverse reactions.

Ms Baloyi inquired as to the attitude of other pharmaceutical regulators toward NVP, and whether it was true that the United States permitted the use of NVP as a component of triple-combination therapy for adults.

Dr Matsuso responded that conditional approval of NVP had recently been lifted in the European Union, and that approval was conditional in numerous other countries. She explained that the triple-combination therapy using NVP was also employed in South Africa, not only in the US. She stated that NVP was not an FDA-approved indication, but that the US Department of Health had granted an allowance for its use by late presenters.

Ms Baloyi also asked how the MCC reconciled its own data findings with those of universities and other pharmacological institutes.

Dr Matsuso explained that the MCC's statutory obligations are written into law, and that it is not responsible for the correction of information from different research sources. Regulations outline what data is acceptable for use by the agency. The MCC must be able to generally apply research information to the broader population.

Dr Matsuso stressed that the role of the MCC was to ensure compliance with safety regulations, and that it was the responsibility of frontline workers (such as doctors) to report to the agency. She explained the differences between spontaneous reporting, active surveillance, and utilization of international reports, and suggested that the MCC required additional resources in order to carry out more active surveillance.

A representative of the MCC added that pharmacovigilance remained reliant on the industry to check itself, and stated that the MCC was encouraging a culture of compliance around reporting, especially where the need for reports of local experiences are concerned.

Ms Rabinovitch (IFP) challenged the validity of the MCC's latest concerns about NVP. There have been no new indications of resistance in children or dangerous reactions, and it appears the MCC's concern emanates primarily from administrative inefficiencies in the Uganda study.

Ms Rabinovitch asked how the MCC functioned in relation to Government, with Bill 90 of 1997 not yet enacted due to court proceedings. She questioned the independence of the MCC vis-à-vis political pressures.

Dr Mathivha addressed the question of MCC independence by asserting that the agency remained insulated from political pressures despite its appointment by the Minister.

Dr Matsuso emphasized that the MCC decision-making process is also independent. Its mandate is to examine the quality and safety of medicines, without recourse to political or commercial concerns.

Ms Rabinovitch also asked Dr Levin of the MCC to confirm whether the SAINT Study established the effectiveness of NVP.

Dr Levin discussed the previously presented data on transmission rates reflected in SAINT.

Ms Kalyan (DP) noted that, while the MCC claims to be independent, it supported the Health Department before the Constitutional Court. She questioned MCC concerns serious concerns about a drug (NVP) already supported in 53 countries, by the World Health Organization (WHO), and by UNAIDS.

Ms Kalyan also asked whether every reported contra-indication must be included on a medicine's package insert.

Dr Matsuso explained the difference between side effects and contraindication with regards to severity and frequency.

Ms Dudley (ACDP) asked what dosage of NVP remained unbanned.

She suggested that NVP was more significant in South Africa due to its cost relative to triple-combination therapy.

With regards to costs, Dr Matsuso stated that the MCC's purview is limited to the quality, safety, and efficacy of medicines.

Ms Dudley asked about the potential impacts of using NVP after the two-month period prescribed by the MCC. She asked if there was a more substantial concern than issues around resistance, and inquired as to the status of NVP in the EU.

Dr Matsuso explained that the two-month stability profile reflected MCC concerns about the degradation of NVP after that time period. She stated that NVP is now fully approved in the EU.

Ms Dudley also mentioned that, in seeking to contact the MCC Registrar, she had been referred several times to the Health Minister's desk.

Dr Jassat (ANC) requested reassurance from the MCC that NVP will not be banned, and asked when its report on registration could be expected. He also requested reassurance that the MCC's decision regarding NVP was strictly scientific, and not informed by political concerns.

Dr Matsuso emphasized that it was within the statutory authority of the MCC to conduct the review. She stressed that concern about resistance was the main motivating factor. As stressed by the WHO, resistance cannot be ignored, and caution must be exercised in approaching situations where resistance is liable to grow.

She went on to reassure the committee that NVP remained indicated for mother-to-child transmission.

Ms De Lille (PAC) requested a clearer comparison between studies in South Africa and Uganda.

She commented that, with NVP licensed for the past four years, doctors are still able to prescribe it as an off-list drug for mother-to-child transmission cases.

Dr Matsuso stated that off-label use is not unusual; governments often permit the prescription of non-approved drugs for reasons of public health.

Ms De Lille also asked whether it was necessary to wait for another, more recent study before the completion of the review.

Ms Kalyan reported that, according to the HST study on 18 pilot sites, there was no scientific evidence supporting the opposition of NVP rollout nationally. She asked why the MCC has found it necessary to review NVP again.

Ms Dudley insisted that Dr Levin explain the "absolute decrease in risk" associated with NVP.

Ms Malumise (ANC) asked what the recent MCC provincial visits indicate with respect to monitoring, safety, and adverse effects?

Mr Ngculu (ANC) inquired as to whether there had been pervasive underreporting in previous studies.

Ms Matsuso explained that the review was consequent to problems with the Ugandan study, and that the US had launched a re-monitoring initiative on the basis of which the MCC would rule.

A representative of the MCC explained that most adverse reaction reporting is from the industry, and that a need exists to ensure extensive reporting by clinicians. The MCC must balance the risks associated with particular medicines against their potential impacts. No system currently exists at the South African test sites to monitor adverse reactions. The MCC continues to wait for the HST report at the end of the year. There is also a need for a statute forcing health workers to report adverse reactions, and raise public awareness of this issue.

Dr Matsuso emphasized that all clinical trials must report adverse effects, and that this did not happen in Uganda.

Mr Ngculu inquired as to the attitude of industry toward the review.

Dr Matsuso responded that the NVP manufacturer had reported to the MCC with respects to research flaws as they were detected, and that the MCC is engaged in an ongoing dialogue with the company.

Dr Matsuso also mentioned that of the 53 countries noted by Ms Kalyan, many had registered NVP on the basis of South Africa's approval. She stressed that South Africa typically follows the precedents set by regulatory bodies such as those in the US, EU, United Kingdom, Canada, Australia, New Zealand, and Sweden. She also noted that the WHO does not register medicines, but has been involved in the pre-qualification process used by the Global Fund for HIV/AIDS.

Mr Ngculu thanked the MCC and committee members for their time and closed the meeting.


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