Johannesburg, 9th July 2015
The National Association of Pharmaceutical Manufacturers (NAPM), echoes the call of the South African Catholics Bishops Conference (SACBC) to the Department of Trade and Industry to prioritise the National Policy on Intellectual Property. Although the draft policy was published in September 2013 and comments have been submitted by the NAPM amongst others, no decisive action on the policy has been forthcoming.
The NAPM acknowledges that innovator pharmaceutical companies should enjoy the benefits of the current 20 years patent protection on their medicines, as a reward for their research and development efforts. However, it is the concept of “evergreening” or the extension of patent protection beyond the original patent term that creates undue benefit for innovator companies, especially when the “patent” gives no real additional benefit to patients.
Although the SACBC’s statement highlights the issues around Intellectual Property, it does not recognise the numerous obstacles which delay the marketing of generic medicines and that Cabinet approval of a “policy document” does not instantly translate into a reduction in medicine prices. The major stumbling block in South Africa remains the delay in the registration of new generic medicines. There are multiple reasons for this; such as the lack of capacity and skills needed to evaluate applications. Recent reports indicate that currently the department receives in excess of 2 500 applications, a very different scenario from 2000, when there were only around 50 new dossiers being submitted each year. It is therefore a national health imperative that critical attention be given to reducing the timelines of the registration of generic medicines.
As an Association the NAPM urges Parliament to speed up the approval of Bill 6, which will bring into being the South African Health Products Regulatory Authority (SAHPRA); which will succeed the Medicines Control Council and importantly be able to raise its own finances, thereby allowing it to employ skilled personnel outside of the conditions of the Public Service restrictions.
It is expected that SAHPRA will be created on a similar basis as the Food and Drug Administration Agency (FDA) in the US and be responsible for their own resources.
Once up and running, it is anticipated that the new body will drastically reduce the current status quo of four to five years for the average registration of generic medicines. The NAPM believes that this will lead to realistic market competition with the public ultimately benefiting from lower prices and greater access to medicines.