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Vested interests resist reform in medicines

The government's efforts to reduce the price of drugs have run into a wall, writes PAT SIDLEY

THE pharmaceutical world as we know it will change dramatically if the Health Department has its way.

But its efforts to reduce the costs of drugs to consumers are being opposed by pharmaceutical companies, doctors, pharmacists and others with a stake in the industry.

If South Africa had a well-organised lobby of consumers, they would be cheering on the department in many of its moves, as these are designed with ordinary people in mind.

Two Bills are currently bogged down in the politics of trade resistance.

The Medicines and Related Substances Control Act has an amendment in the pipeline. It was supposed to have been presented to parliament last week, but found its way instead to the law drafters to get it into shape before it goes to parliament.

It contains many of the measures the pharmaceutical companies and dispensing doctors have been fighting against and is likely to be softened in response to the pressure from the industry.

The other Bill in the pipeline is the Pharmacy Amendment Bill which will, among other things, change the current situation regarding pharmacy ownership, where only pharmacists may own pharmacies.

In reality, this contentious issue is likely to land up with conditions qualifying its application, perhaps in the form of regulations which are yet to be published.

Kathy Walstead-Plumb, CEO of managed-care company Southern Healthcare, says SA medicine prices are simply "the highest in the world".

Certainly, they are among the highest in the world to private-sector consumers.

Medicines in South Africa constitute about 30% of the annual spend on health care of medical aid organisations.

In the US, according to Southern Healthcare, the comparable figure would be between 12% and 14%. Figures put out by the Representative Association of Medical Schemes illustrate the kind of impact our medicine prices have on our pockets. In 1990, medicine costs rose 37% from the previous year. The next year they rose another 45% and in 1995 they were up 14% from 1994.

Reducing these costs was among the early tasks the Health Department set itself, and its National Drug Policy was an early and good example of a well considered, comprehensive policy document - but the subsequent haggling has ensured that little has been done.

Initially, the department hoped to see:

  • Generic prescribing to increase the use of cheaper generic substitute drugs.
  • Limitations on dispensing doctors to curtail their activity severely.
  • Drastic curtailing of how drugs are marketed to dispensing doctors to end the practice of "bonusing" and limit "sampling".
  • An essential drugs programme with an essential drugs list ensuring that the drugs available for use in public hospitals and clinics are the least expensive, most basic and most needed drugs. This, at least, has been implemented;
  • Parallel imports of branded drugs, and international tendering for generics to be supplied to state health-care facilities;
  • Leaflets containing patient information.
  • Child-proof containers.
  • Deregulation of the ownership of pharmacies; and
  • An end to percentage mark-ups when prescribed medicines are dispensed. If all failed, the minister would consider price controls.

    An attempt in July last year to make some of the wish-list reality floundered before it could become law. A set of regulations published for comment inspired the ire of the pharmaceutical industry. Using one section of the regulations in particular (a new packaging marking system aimed at controlling the theft of drugs), SmithKline Beecham took legal action against the department and the proposed regulations were withdrawn.

    But the pharmaceutical industry is also objecting to mandatory generic prescribing, which they find too restrictive, and the curtailing of their access to dispensing doctors. Aspects of giving patient-friendly information to consumers with package inserts and dispensing drugs in child-proof containers are also in contention.

    Some of the objections have found their mark and by the time the Medicines and Related Substances Control Amendment Bill gets to parliament, it will have been watered down. It is unlikely, for instance, that doctors will be forced to prescribe only the generic name. It is more likely that pharmacists will be compelled to advise consumers that they have a choice when there is one.

    In England, prescriptions written in general practice using the generic name increased from 35% in 1985 to 55% 10 years later, according to the authoritative Drug and Therapeutics Bulletin published by the UK Consumers' Association and aimed at health-care professionals.

    The bulletin makes the point, however, that generic equivalents rely on the fact that they must perform in the body in the same way (as safely and effectively) as the branded-name drug they are copied from. The quality of these medicines, according to the bulletin, depends on the licensing, inspection and monitoring systems operated by the drug regulatory authorities.

    Consumers would be more assured if that information was made more accessible to the public. It is regarded as a trade secret in the UK - as it is here. The Consumers' Association has long campaigned for access to information collected by the drug regulatory authorities on the safety of medicines. Perhaps our own Medicines Control Council should be put under the same pressure - especially since the multinational pharmaceutical companies are casting doubt on the council's ability to monitor the safety and effectiveness of generics adequately.

    Meanwhile, retailers are sitting still and holding thumbs on the question of whether or not they will be able to own pharmacies. The Pharmacy Council Amendment Bill allows for the ownership of pharmacies by non-pharmacists in an absolutely unqualified way.

    But the Bill has to survive the parliamentary portfolio committee on health, first, and then the process of lobbying. Pharmacists are likely to raise the roof on this one. And when a measure appears in final form it is likely to be alongside regulations which may well set up further conditions for the operating of pharmacies.

    Hopefully, consumers in South Africa will start making their voices heard and show their support for the Health Department's efforts to bring down the cost of medicine.

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