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Experts hammer out drugs rules
by Pat Sidley
2001-05-04

Now that pharmaceutical court action has stopped, act can be promulgated. Health department drug experts have spent the past two days drawing up proposed regulations for the Medicines and Related Substances Control Amendment Act of 1997 so that it can be promulgated and put to work as soon as possible. High on the list are proposed regulations to deal with parallel importation such as who would be licensed to do the importing, whether and how imported medicines would be registered and how this would be monitored, according to one of the health department's advisers on drug issues, James Love, of the Consumer Project on Technology, a Ralph Nader group. In the armoury of provisions hoped to have the effect of dropping prices are a fixed single exit price for medicines that will not be varied by discounts; increased use of generic copies in prescriptions; and the ability to import brand name drugs available at lower prices outside SA than in it. (Source: Business Day, 26 April 2001)

Now that pharmaceutical court action has stopped, act can be promulgated. Health department drug experts have spent the past two days drawing up proposed regulations for the Medicines and Related Substances Control Amendment Act of 1997 so that it can be promulgated and put to work as soon as possible.

High on the list are proposed regulations to deal with parallel importation such as who would be licensed to do the importing, whether and how imported medicines would be registered and how this would be monitored, according to one of the health department's advisers on drug issues, James Love, of the Consumer Project on Technology, a Ralph Nader group.

In the armoury of provisions hoped to have the effect of dropping prices are a fixed single exit price for medicines that will not be varied by discounts; increased use of generic copies in prescriptions; and the ability to import brand name drugs available at lower prices outside SA than in it.

On the HIV/AIDS front, the government's marked lack of interest in the provision of antiretroviral therapy in the short term has put the spotlight on the private sector to take the lead in the provision of antiretroviral medicines. Anglo American is committed to finding a way to provide antiretrovirals to workers, according to Brian Brink.

Medscheme, the largest medical aid administrator in the country, already provides nearly 10000 of its members with antiretroviral therapy through its Aid for AIDS programme. But the prices it has access to, without a supply of cheaper generics or because multinational suppliers will not extend price-cut offers to the private sector, prevent it from making more medication available to more members.

Indian generics manufacturer Cipla has offered a cocktail of three drugs to the government at 600 a patient a year. It would offer the same cocktail to not-for-profit organisations for $360. Local generics manufacturer Aspen Pharmacare could supply the same cocktail for $347 a year, its CEO, Steven Saad, said.

But that cocktail may not be offered here in generic form, as the three different manufacturers have patents over the particular drugs, and not all of them have included the private sector in their offers of price cuts in terms of the UNAIDS accelerating access initiative. Bristol-Myers Squibb's portion of the Stavudine cocktail, for instance, costs R1000 a month in the private sector. BMS has told Aid for AIDS it will not extend its offer to Medscheme's programme, says Leon Regensberg of Aid for AIDS.

Source: Business Day, 26 April 2001

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