The withdrawal of the pharmaceutical industry from the court case is being celebrated as a victory for the South African government and AIDS activists, but in reality it is the start of a long journey towards access to affordable medicine.

Health minister Dr Manto Tshabalala-Msimang said government did not delude itself that the end of the court case was the end of the struggle for access to affordable medicines.

“In reality, we are only at the start of a long and arduous journey and this law is merely a vehicle,” she said.    

Her comments follow the withdrawal of an application to have the Medicines and Related Substances Control Amendment Act declared unconstitutional by the Pharmaceutical Manufacturers Association (PMA) of SA, a trade organisation representing the pharmaceutical industry in South Africa.

PMA Chief Executive Officer Mirryena Deeb said the decision to withdraw was taken after government agreed to abide by the TRIPS agreement, involve industry in the drafting and finalisation of the Act’s regulations and respect the industry’s constitutional rights. A joint working committee will also be set up to consult on and consider broader issues.

Secretary of the Treatment Action Campaign, Mark Heywood was jubilant, but cautioned that as far as access to treatment for people with HIV/AIDS was concerned, the provisions of the Act should not be over-exaggerated.  

“Clearly it’s a victory,” said Heywood. “No concessions were made by government, there will be no re-wording of Section 15c, the PMA withdrew unconditionally. The assurance from the South African government that it will respect the TRIPS Agreement is nothing new.”

The Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS) stipulates that all its signatories (members of the World Trade Organisation) must give drug companies 20 years patent protection on their inventions.  

TRIPS includes the right of nation states to issue compulsory licences which give a local firm the right to make a copy (generic) of an expensive patented drug at a lower price, while compensating the patent holder.  

This right may be used where a patent holder (the manufacturer who first registered the invention or drug) can be shown to be abusing its monopoly position, or in cases of national emergency.

Deeb said government had indicated that compulsory licensing and parallel importation would be used only “occasionally”.  

Tshabalala-Msimang said she was pleased that the industry had “finally recognised both the legitimacy of our struggle for affordable healthcare and the genuineness of our respect for international trade treaties that we are party to.

“The resolution of this court case only confirms our view that international markets have no inbuilt conscience.”  

The relationship between government and the pharmaceutical industry soured in February 1998 when the PMA instituted legal action against government to defend the industry’s patent rights.

Action on the part of industry was specifically aimed at Section 15c of the Medicines Act.

Section 15c allows the government to import the same medicine sold by the same company or its licensee at a lower price in another country.

The minister said the Act will now be promulgated with draft regulations relating to various sections of the Act published for comment within a few weeks.

The Medicines Act introduces four important elements to contain health care costs:

  • Mandatory generic substitution of medicines that are no longer under patent. A pharmacist must offer a patient the generic version of a brand name medicine. A generic medicine is a drug with the same quality active ingredient as a brand name drug. It is usually considerably cheaper than the original drug.
  •  The introduction of a pricing committee that will set up “transparent pricing mechanisms”. Pharmaceutical companies will have to justify the prices they charge.  
  •  The provision for parallel imports. This allows for international tendering for medicines used in the public sector. Certain aspects of the Act, such as the prohibition on sampling and the provision of incentives and bonuses by the industry, will kick in automatically with promulgation.  

Heywood cautioned against reports that the court victory would suddenly usher in cheap anti-AIDS drugs.”That is nonsense. Generic anti-retrovirals will only be permissable if government issues compulsory licences,” he said.  

GlaxoSmithKline’s (GSK) CEO Jean-Pierre Garnier said they were determined to play a part in addressing the healthcare needs of South Africa and other countries in the developing world. He also acknowledged the key roles played by UN Secretary-General Koffi Annan and President Thabo Mbeki in securing a settlement.

He said GSK was ready to supply anti-retroviral medicines to South Africa at heavily discounted prices.