THE regulations setting out the process through which medical doctors have to obtain a licence before they can sell and dispense medication directly to patients have been brought back to life through a decision of the Supreme Court.

The regulations were resuscitated on Thursday last week, when the Supreme Court ruled in favour of an appeal by the Minister of Health and Social Services, the Medicines Regulatory Council, the Registrar of Medicines and the Attorney General against a High Court decision dating from the end of June 2010.

The Medical Association of Namibia and Tsumeb-based doctor Pieter Pretorius still scored a notable victory in the appeal judgement, though, with a section of the regulations which had been issued under the Medicines and Related Substances Control Act in July 2008 declared unlawful and beyond the powers of the Minister of Health.

In the High Court, the Medical Association of Namibia and Dr Pretorius succeeded in having the regulations set aside in their entirety, based on a finding by the court that the correct legal processes had not been followed when the regulations were published and put into operation.

That part of the High Court's decision has now been overturned in a judgement by Acting Judge of Appeal, Johan Strydom, supported by Judge of Appeal Sylvester Mainga and Acting Judge of Appeal Pius Langa.

The part of the regulations requiring the Medicines Regulatory Council to consider whether there are pharmacies in the vicinity of the practice of a doctor who applies for a licence to dispense medicines, however, did not survive the appeal.

"The purpose for the dispensing of medicine is to heal or to bring relief to people who are ill or in pain and in need of treatment for their illnesses," Judge Strydom said in the court's judgement.

"There exists no need to limit access to medicine to pharmacists to the exclusion of medical practitioners, and there is, in my opinion, also no reason why people should not have a free choice whether to obtain their medicine from a medical practitioner or a pharmacy," he stated.

While he accepted the argument that pharmacists are better qualified to dispense medicine that doctors are, he also noted that nothing had been placed before the court to show that doctors are not well qualified to do what they have been permitted to do since 1965, which is to supply certain types of medication to their patients directly.

In terms of the 2003 Medicines Act, health care providers, including medical doctors, would only be allowed to sell and dispense medicines to their patients from their consulting rooms once they had obtained a licence from the Medicines Regulatory Council. The council has to consider whether it is "in the public need and interest" to grant such a licence to a doctor.

According to the Medical Association of Namibia and Dr Pretorius, the Registrar of Medicines refused the applications of all of the doctors who applied to be issued with the required licence after the Act and its regulations had come into operation.

The reason given was that all of the doctors who had applied were practicing medicine in locations where there were also pharmacists available, and that pharmacists were better qualified to dispense medicine than doctors are.

After the Medical Association and Dr Pretorius had launched their challenge against these refusals and the regulations themselves in the High Court, all of the parties involved agreed that the Registrar of Medicines' actions had been invalid, as the decisions should have been taken by the Medicines Regulatory Council instead of the Registrar.

In the High Court's judgement, it was ruled that the predecessor of the Medicines Regulatory Council, the Medicines Control Council, had not been validly appointed, with the result that the Minister of Health could not have consulted with the council as required by the law before the regulations were issued.

The Supreme Court came to the opposite finding on that point.

The High Court also found that, because the draft regulations were published in November 2004, before the the Medicines Act had come into operation, the regulations had to be declared invalid.

In the Supreme Court's decision, Judge Strydom concluded that it had been necessary to publish the draft regulations after the Medicines Act had been passed by Parliament but before it had come into operation, so that people could comment on the draft before the Act and the final regulations were implemented.

The part of the regulations requiring the Medicines Regulatory Council to take into account factors such as the existence of pharmacies in the vicinity of the practice of a doctor applying for a licence was a drastic change of policy, which was being introduced by way of regulation, and was something which the Minister of Health was not empowered to do, the court ruled.

Senior counsel Raymond Heathcote, assisted by Hannchen Schneider, represented the Medical Association ad Dr Pretorius. Geoff Budlender, SC, assisted by Nixon Marcus, represented the appellants.