It has been over six years since government began developing the draft policy on intellectual property (IP) that has been the focus of major public controversy following the PharmaGate scandal, which involved a leaked pharmaceuticals industry email by Knowledge Ecology International in January.

The emails confirmed the direct involvement of multinational pharmaceuticals companies and industry body representing multinational pharmaceuticals companies in South Africa Innovative Pharmaceuticals Association of South Africa (Ipasa) in bypassing South African IP law.

“The draft policy proposes measures that will improve the ability of all in South Africa to access life-saving medicines. Whether or not the current African National Congress-led government can finalise a good policy presents a clear and concrete test of both its commitment to improving the health system – a Constitutional obligation – and its ability to deliver essential policy reforms.

“Without urgent finalisation of the policy, South Africa will continue to face excessively high medicine prices. Only generic competition has consistently been proven to bring drug prices down to their lowest level, yet generic competition is often blocked in South Africa owing to low-quality patents,” says healthcare activist group Treatment Action Compaign (TAC) activist Lotti Rutter.

He adds that many medicines continue to be priced far out of reach of ordinary South Africans. For example, breast cancer treatment Trastuzumab costs over R550 000 for annual treatment, which is higher than in India, Belgium or even the UK.

Depression treatment Aripiprazole costs 35 times more locally than in India and will remain under patent protection until 2033. Linezolid, one of the only effective treatments for drug-resistant tuberculosis, is priced at R676 a pill, while it is available at only R25 a pill in India. Cancer treatment Imatinib is 91% more expensive than the generic equivalent in India.

“These are not standalone cases and they are costing the government billions and ballooning South Africa’s pharmaceuticals trade deficit,” Rutter claims.

TAC first learned of the IP policy in September 2011 in a letter from then Department of Trade and Industry (DTI) Minister Dr Rob Davies, who explained the policy would “ensure that the flexibilities relating to access to medicines and health are incorporated into national legislation”.

Rutter says: “Ipasa would have you believe that the process has been rushed and unconsidered – that additional time should be set aside to assess the situation and proposed solutions. The leaked PharmaGate documents showed a R6-million strategy to delay the process in just this way.

“Whatever Ipasa may say, the truth is that there has been extensive consultation on the policy. Both industry and civil society have had ample opportunity to state their positions in submissions and in face-to-face meetings – in fact, industry has had better access to officials in the DTI, gaining prior access to documents and influencing the drafting process,” he claims.

In August 2011, the DTI held a meeting to solicit views from external stakeholders in shaping the IP policy. Civil society was not present at this meeting and instead found out after the fact, in a letter sent out in September 2011.

In September 2011, Davies wrote to the TAC to say that the DTI was developing an IP policy to ensure that flexibilities relating to access to medicines and health are incorporated into national legislation.

The DTI shared an early draft of the IP policy with the TAC and humanitarian organisation Doctors Without Borders (MSF), in May 2012, promising that the IP policy would be released for public comment in July 2012.

The May 2012 draft document included extensive comments from the pharmaceuticals industry, revealing that the industry was consulted prior to May 2012, as well as showing the involvement of civil society.

Among other meetings and consultations, the DTI hosted the Africa IP forum in February 2013, which was attended by many IP experts from across the world. Given the repeated missed deadlines to release the IP policy, TAC picketed the forum.

In August 2013, TAC, human rights organisation Section27 and MSF delivered a memorandum of demands at a DTI workshop on IP held by the World Trade Organisation (WTO), the World Health Organisation (WHO) and the World Intellectual Property Organisation (WIPO).

The Draft National Policy on Intellectual Property was released for public comment in September 2013. TAC, Section27 and MSF submitted a joint submission of recommendations to the DTI. Comments were also submitted by Ipasa, the National Association of Pharmaceutical Manufacturers and a coalition of academics specialising in IP.

In December 2013, at the third Global Con- gress on Intellectual Property and Public Interest held in Cape Town, a representative from the DTI indicated that the policy would be finalised and released in early 2014.

In January, a plot supported by the IP committee of Ipasa and drawn up by American public relations firm PAE was exposed in the Mail & Guardian. A central aim of the plot was to delay finalisation of the policy until after the elections.

Shortly after the PharmaGate scandal broke in January, Davies told website IP-Watch that the policy “is not likely to be completed before the end of this administration”.

However, DTI chief director of intellectual property Macdonald Netshitenzhe told a daily newspaper that the policy was expected to be submitted to Cabinet in March.

“The reforms proposed in the draft policy are not radical. Each reform is entirely lawful and is sanctioned by the WTO, the WIPO and the WHO.

“Each reform is in accordance with the Trade-Related Aspects of Intellectual Property Rights agreement. Similar reforms have already been implemented in other developing countries, such as Argentina, Brazil and India. There is no legal reason to delay the policy any further. To the contrary, the Constitution demands that such reasonable legislative measures that would increase access to healthcare must be implemented,” Rutter concludes.