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  • Shaun Bateman

The Inability of South Africa’s Drug Regulator

One of the most frustrating problems that has plagued the South African pharmaceutical landscape for at least the last decade is the inability of South Africa’s drug regulator to approve medicines in a timely manner. The drug regulator can take more than six years to approve a drug that oftentimes has already been approved by an advanced country drug regulator. This tardy approval process has resulted in a backlog of an estimated 16,000 drugs waiting for marketing approval. Not only do these delays reduce revenues and increase costs to drug makers, they deny and retard patients’ timely access to the medicines.


Although some people may consider it necessary to have a local regulator to ensure that products are safe, bureaucratic inertia is denying thousands of South African patients’ ready access to medicines which have already been approved elsewhere that could cure or manage their symptoms. For cancer and HIV patients, these delays could be fatal. Approximately half of the drugs waiting for approval are for new registrations of a medicine, which are available and in use for patients overseas, but not locally. Half of these drugs have been on the marketing approval waiting list for more than five years. According to one drug manufacturer, it has waited up to seven years for a regulatory decision on some of its products and currently has over 250 dossiers awaiting approval.


If a drug is not registered with South Africa’s drug regulator – the South African Health Products Regulatory Authority – then the patient can sometimes gain access to it through a Section 21 permit, which allows them to import it from overseas. However, this is a costly process since medical aids will not reimburse a patient for an unregistered medication and although this may come as some relief to those patients who are able to afford the drug through out-of-pocket payments, it fails to address the underlying cause of why patients are not gaining access to drugs in a timely manner in the first place.


A lack of human resources is one contributing factor for the backlog. Another may be the government’s pro-generics policy. The legislation governing the drug regulator, which was ironically introduced several years ago as part of a drive to increase access to medicines, 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 the regulator being overwhelmed by registration applications from generics manufacturers, a process that continues to this day. This policy must be scrapped as a matter of urgency


It is encouraging to note that the chairperson of the board of the SAs drug regulator, Prof Helen Rees, has suggested that the regulatory authority will refer to prior reviews from other regulators when registering drugs. This makes a lot of sense as most drugs are first reviewed by either the United States’ Food and Drug Authority (FDA) or its European Union equivalent, the European Medicines Agency (EMA), prior to market authorisation. Manufacturers typically then register in smaller markets such as South Africa.


While referring to reviews from other regulators is an important first step towards achieving a modernised, efficient drug regulatory system, things could be much better. For example, Singapore has selected drug regulators from six countries (US, Canada, Switzerland, Japan, Australia and New Zealand) and the EMA so that, if a proposed new drug is approved by two or more of these regulators, the drug obtains automatic approval within 90 days of filing for registration. As a result, Singapore is one of the top medical tourism destinations. If it had not adopted this approach, it is unlikely that its medical tourism industry would have developed because patients would not want to be treated with products that could be several years behind the times.


Manufacturers are deterred from investing and setting up manufacturing plants in a country where they are faced with an unpredictable, inefficient or delayed market approval process because they do not want their capital investment sitting idle while the local drug regulator plods along in carrying out its reviews. This simple insight is obvious to some policymakers in some countries such as rising pharmaceutical powerhouses like Singapore and Ireland. It is apparently mystifying to others who may wonder why they remain investment ‘fly over’ zones year after year.


For a middle-income country such as South Africa struggling under multiple health burdens and strapped for resources, the practical policy choice to increase access to medicines and save lives, as well as to save on scarce resources, is to automatically approve drugs (both generic and innovator) that have already been approved by advanced country drug regulators.

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