Eleven years ago, South Africa's healthcare system became the pariah of the world when the government failed to address HIV/Aids. Since then, the country has spent R68-billion combating the epidemic - but it seems that the government, despite the weak economy, will have to dig deeper into its pocket to meet its 2030 Aids-free mandate.Preventative strategies may add to the state's financial burden as it looks at rolling out the use of pre-exposure prophylaxis to prevent the contraction of HIV/Aids, through the use of the antiretroviral drug Truvada.According to guidelines released on September 30 by the World Health Organisation, the drug should be administered to HIV-negative individuals who have "high-risk" profiles, including sex workers, men who have sex with men and women between the ages of 15 and 24.Professor Helen Rees, executive director of the Wits Reproductive Health and HIV Institute, said the Department of Health was seriously considering the possibilities of introducing pre-exposure prophylaxis in South Africa.story_article_left1"This is a massive undertaking; it's on the same scale as introducing a new contraceptive," she said.But the good news for the healthcare system may be bad news for the health budget.Rees said the restricted health budget would have to be revised to make provision for the new preventative measure."The health budget is finite, so you would have to decide where you would have a trade-off," she said.South Africa's 2015 total healthcare budget was R136-billion, with R22-billion allocated directly towards HIV/Aids programmes.The country's antiretroviral budget makes up R14-billion of the total HIV/Aids budget, which goes towards the cost of drugs, laboratories and human resources.Dr Yogan Pillay, the deputy director-general of HIV, TB and women and child health at the Department of Health, said the cost of treating the virus has accumulated significantly since the start of the roll-out of antiretrovirals in 2004. "It increases each year because we put new patients on treatment each year," he said.The department has 3.1million patients on antiretroviral treatment - the largest number of people on treatment in the world.The price of antiretroviral treatment was marked down from R314 per patient to R89 per fixed-dose combination. This is a combination of several drugs that need to be taken together.Health Minister Dr Aaron Motsoaledi, reflecting on the early days of the government's HIV treatment programme, said that 10 years ago it cost the state R10,000 a year to treat one patient, but the introduction of the fixed-dose combination in 2012 had helped cut costs by 99%.However, with the fluctuation of the rand, the latest price cannot be fixed."Of course, the R89 has changed dramatically because of the fall of the rand, and because of the dollar exchange rate of most active pharmaceutical ingredients," Motsoaledi said.story_article_right2However, despite the recent strain on the economy, Motsoaledi believes the introduction of pre-exposure prophylaxis will not have a significant effect on the health budget, as "the country has been able to treat more people with the little resources that we've got and it has not been a problem".Stavros Nicolaou, a senior executive for strategic trade and development at Aspen Holdings, said active raw materials carried a duty of about 10% to 15%, but when you imported a pharmaceutical product there were zero duties and zero tariffs.Aspen's South African subsidary, Pharmacare, has submitted an application to the Medicines Control Council for the approval of the pre-exposure prophylaxis on its existing ARV, Truvada.Vivian Frittelli, CEOof the National Association of Pharmaceutical Manufacturers, said the challenges of introducing new medication in South Africa would be the patent protection clauses that may mean generic companies such as Aspen would not be able to copy the drug until it was out of the patent period. That could take up to 20 years.In the past, pharmaceutical companies had received a licenc e from the patent holder to produce the drug, but creating new drugs for developing markets such as South Africa remained a challenge as at least 70% of all drugs used in the country were imported, he said."We don't really have the development capabilities that they have overseas, so that's one of the drawbacks."US-based Gilead Sciences has been extensively involved in pre-exposure prophylaxis research and has applied for its use in the US.Nicolaou said the volumes in the public sector were different to those in the private sector as the public sector accounted for 80% to 85% of the population , and the private sector 15% to 20%."The economies of scale are much bigger in the public sector and your procurement is centralised. The cost of distribution is less in the private sector than the public sector."Nicolaou said the scale of providing pre-exposure prophylaxis to the public sector would be different to that of the private sector, as the "public sector is subsidised by the private sector - otherwise we'd never be able to afford [medication] for the poorest in the country ".story_article_left3Health insurance company Discovery Health will have to rework its strategies to cover its members for this medication.Noluthando Nematswerani, a divisional manager for HIV and mental health at Discovery, said one of the biggest challenges in providing medical aid for people who would use pre-exposure prophylaxis was adherence to treatment."Poor compliance results in poor outcomes, so you are making an investment but you don't actually see the gains."Nematswerani said that because the scheme invested so much money, it needed to see good outcomes.Although the government has not taken any official position on pre-exposure prophylaxis, Motsoaledi confirmed that he would meet different stakeholders to discuss the roll-out of the drug."Ever since we started this war against HIV in the country, people have been asking us about the cost and whether the country will be able to afford it. My answer has always been standard: 'Can the country afford not to?'" Motsoaledi said.tshandup@sundaytimes.co.za..