The Medicines and Related Substances Amendment Bill (medicines bill) was published in April and there is widespread agreement that it is one of the most important pieces of health legislation to be proposed in recent years.

The proposed bill seeks to replace the inefficient and overburdened Medicines Control Council (MCC) with a new regulatory authority, and it gives the health minister the power to turn down an application to register a medicine on the grounds that it is not in the public interest.

This is in contrast to international regulatory bodies, which operate on the premise of that medicine registration is a technical process overseen by a specialist body that considers safety, quality and efficacy and are independent of political structures.

The health department has been accused of hasty drafting and being hell bent on rushing the bill through parliament before the general elections early next year.

However, in a move seen as a rejection of the two-tier system, parliament’€™s health committee has asked the State Law Advisors to prepare a text that would enable the new regulatory authority to register on the basis of safety, quality and efficacy.

Next week the committee will continue to look at the provisions that create this proposed authority.

The health committee recently held several days of hearings into the late night with most presenters calling for medicine registration to remain a scientific and technical process.

They called for registration of medicines to be based on efficacy, safety and quality and not political considerations.

The Treatment Action Campaign and Aids Law Project (ALP) have been clear that the proposed legislation would undermine the new regulatory authority’€™s independence.

They said the proposed two-tier system went beyond safety, efficacy and quality and questioned what it would mean if the minister was allowed to regulate in relation to public interest.

‘€œBy introducing this it would create uncertainty and delays and there would definitely be litigation if certified products are stopped from reaching the market,’€ ALP lawyer Jonathan Berger told the committee.

Democratic Alliance (DA) spokesperson on health Mike Waters said the health committee’€™s decision to reject the two-tier system would ‘€œavert a chaotic situation in medicines regulation where medicines are denied to South Africans for political reasons’€.

He said the DA had been arguing that a system whereby the Minister of Health is required to give the final say-so for the approval of any medicine would not only slow down the process of medicines approval dramatically, but would also result in medical decisions being made on political grounds.

‘€œWe believe that that the MCC is in desperate need of reform. Its antiquated structure creates enormous delays in approvals,’€ said Waters.

Dr Anban Pillay, Chief Director Health Economics in the health department has said in the past that efficacy, safety and quality would not be compromised. He said a body similar to the MCC would investigate the efficacy, safety and quality of a drug.

A ‘€œdeclaration’€ would then be made and a certificate issued. The company would then be able to export the medicine to a market outside of South Africa. However, if its intention was to sell it locally, then it would be scrutinized by committees in accordance with its benefit to the population, the burden of disease and its appropriateness for the local market.

The pricing committee would rule on the value for money of the drug in question.

‘€œThese committees have to report to someone to make the final say and it has to be the minister,’€ said Pillay.   He denied that the process would be slowed down significantly stating that many of the applications could run in parallel.

According to Pillay, international evidence showed that government would also have more bargaining power in terms of pricing if the drug was not registered until an agreement was reached on the price.

He confirmed that if the bill was accepted, every new drug application would have to go via the minister for final approval, based on the recommendations from the various committees.

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