In almost all countries, regulators review new medicines to check they are safe and effective. Because of a regulatory bottleneck, drugs already approved and in use in other countries are being kept from South African patients.
Data from the Department of Health shows that it takes on average 37 months for a generic medicine to be approved, and 38 months for an innovative medicine.
Only 70% of new medicines targeted for priority fast track review — cancer, HIV, tuberculosis medicines and vaccines — are approved within two years, according to government figures.
The official account of the cause for the delays makes for depressing reading. “Old medicines applications dated from the 1990s still in system. Unable to comply with current regulatory requirements. Lack of experienced and skilled valuators”, says the MCC in one report.
A lack of human resources is clearly one contributing factor. Another may be the government’s pro-generics policies, implemented through the Medicines Act in 2003, ironically, as part of a drive to increase access to medicines. This legislation mandated importation of cheaper drugs from overseas and the compulsory substitution of innovator drugs with generics within the public health system.
Somewhat predictably, the reform led to an explosion of registration applications by generics manufacturers — more than 2,500 between 2007 and 2012 alone, according to researchers at the University of the Western Cape.
The meagre resources of the MCC were overwhelmed and it continues to struggle with the sheer volume of applications.
One solution to this capacity problem is for the MCC not to attempt to undertake the entire review process itself, but rather to draw on the work of larger, better-resourced foreign drug regulators. This would prevent duplication of efforts, save public money and speed up access to medicines.
Towards the end of last year the Registrar of Medicines, Dr Joey Gouws, told an international conference of drug regulators in Cape Town that they should no longer work separately from each other, but converge, such as by working with the US Food and Drug Administration (FDA).
This makes a lot of sense as most drugs are first reviewed by either the FDA or its EU equivalent, the EMA, prior to market authorisation. Manufacturers typically then register in smaller markets such as SA. Greater regulatory convergence would mean that smaller countries save time and money by relying more on the expert judgment of the bigger regulatory bodies. It would mean less duplicative work and quicker review times.
Currently, according to Dr Gouws, there is no regulatory convergence between SA and other countries, which means regulators do not even share with SA reports on already reviewed drugs.
An encouraging sign, though, is that in April the MCC will become the South African Health Products Regulatory Agency, with new legislation allowing for the sharing of information with other regulatory agencies.
The MCC has already signed memorandums of understanding with Switzerland and the UK as reference countries in the drug approval process. Other agreements in the works are with the World Health Organisation for priority medicines; Brazil for medical devices; and China for active pharmaceutical ingredients.
While sharing information with other regulators is an important first step towards achieving a modernised, efficient drug regulatory system in SA, things could be much better.
In early 2017, Saudi Arabia and Egypt will introduce new drug approval systems that reference decisions made by the US FDA. These policy reforms will slash their current regulatory approval timelines for pharmaceuticals from 12-36 months, to one or two months — a reduction of more than 90% that will be a boon to patients.
For middle-income countries struggling under multiple health burdens and strapped for resources, this is a sensible, cost-free reform that will save lives. It is one that we should emulate in SA.