1. DISCOVERY HEALTH COMMENTS ON THE MEDICINES AND RELATED SUBSTANCES BILL August 2008

2. Overview of Comments Aims and objectives of the Bill are welcomed Establishing a comprehensive registration process Inclusion of economic evaluation Maintaining an accurate register The Single Exit Price regulated as the Maximum Allowable Price Strengthening the Certification Process Addressing undesirable practices

3. A welcome development Rationalising the regulation and control of drugs, medicinal cosmetics / foodstuffs and medical devices will prove beneficial to industry and consumers It is hoped that the capacity of SAHPRA will be suitably strengthened in order to support its widely expanded scope Transition arrangements towards the new registration process should be unambiguous and structured for optimum efficiency

4. A comprehensive registration process - 1 Assessing the economic benefit of a medical product 1. Ensuring price and cost – effectiveness Product is registered at a discount price, while undergoing evaluation. Pricing may be increased or the product withdrawn when sufficient evaluation data is obtained 2. Allow risk sharing arrangements Medical schemes and the manufacturers of medicines and related products may agree to share risk on new technologies, until the true clinical value of the product has been evaluated

5. A comprehensive registration process - 2 Maintenance of an accurate comprehensive register Product register to include generic substitution status To capture health technology evaluation status To have accurate updated records of the applicable price To retain records of historical prices Undertake classification of medical products according to a national systematic identification standard SAHPRA should be empowered to be the national custodian of the identification standards

6. A comprehensive registration process - 3 Amend pricing legislation to improve the definition of the Single Exit Price In order to strengthen a price protective environment Define the Single Exit Price as the Maximum Allowable Price This allows the implementation of bargaining power to obtain prices lower than SEP This amendment retains current protection where prices may not be higher than the SEP

7. Strengthening the certification process The function of certification of medical products is one that requires the application of technical expertise and independent judgement In most comparable countries, this function is performed by an independent Advisory Committee It is proposed that the Bill empowers the Minister to appoint an independent Advisory Committee A further proposal is that the Minister’s approval / declining a request for certification will be informed by recommendations from the Advisory Committee

8. Addressing remaining undesirable practices The Bill defines how sampling of products will be regulated However the common practice of giving health practitioners free devices in return for practical “evaluation” should be properly regulated Another common practice is the provision “free” CAPEX items to medical facilities. This practice should be prohibited as it encourages the purchase of expensive consumables associated with the equipment provided.

9. DISCOVERY HEALTH COMMENTS ON THE MEDICINES AND RELATED SUBSTANCES BILL August 2008 mandim@discovery.co.za www.discovery.co.za