Delays in drug registration hamper access

In the SA market, Intellectual Property Rights (IPR) protection lasts for a maximum of 20 years but the registration process consumes a significant portion of the time period allowed to recoup costs due to the lengthy period of time (sometimes up to 5 years) taken by the Medicines Control Council (MCC) from the date of submission of a drug to the date of approval. This lack of time to recover costs reduces the commercial value of the product, deters research and development (R&D) and hampers access to medicines, which could have potentially deleterious consequences for patients that need these drugs.

Delays in registration also have the unintended consequence of potentially opening the door for fakes and/or sub-standard drugs. Consider for example some doctors and/or patients that are aware of the availability of certain drugs in other countries. These individuals will do what they have to in order to get hold of the drug that they are after. However, these drugs may not contain the correct amount of active ingredient. Moreover, in many cases, fake drugs contain harmful chemicals that not only fail to treat the underlying ailment but also cause direct harm to the patient. Of particular concern are fake drugs that do contain some active ingredient. These drugs increase the probability of resistance emerging to good quality drugs and this has the potential to render an entire class of drugs useless and introduce serious long-term implications for our ability to fight disease.

Although some may consider it necessary to have a regulator to ensure that products are safe, it is no use if the delays caused by the size of the task are preventing life-saving drugs from entering the market. More specifically, there is little justification for the MCC simply to fulfil a bureaucratic requirement to withhold medicines from South Africa’s sick, if some of these same drugs have already been registered for use in the United States, European Union, Japan and other developed nations.

There is a simple policy proposal that will reduce the amount of time required to register drugs thereby increasing access to medicines and reducing the opportunity for fake and/or sub-standard drugs entering the market. Any drug already approved by advanced country administrations should go through an accelerated approval process in South Africa. For example, the MCC can choose a handful of stringent drug administrators that it deems competent, such as the United States Food and Drug Administration (FDA), European Drug Administration, Japanese Drug Administration etc., and any drugs that have been approved by these regulators should simply gain automatic approval in SA. On receipt of such an application the MCC should advertise the intention to proceed with registration unless a substantiated objection is received within a specified period. If the MCC determines that the objection is valid, then it proceeds with whatever action (such as clinical trials) that might be necessary to address the concerns stipulated in the objection and determined as valid by the MCC.

This proposal will free up valuable resources, particularly skilled MCC staff that can then concentrate on ensuring the efficacy of the drugs already on the market. Unnecessarily high registration costs, delays in registration, and the curtailment of the patent life of pharmaceuticals borders on infringing the Intellectual Property Rights (IPR) of the applicant drug companies and risks opening the door for fakes and/or sub-standard medicines that not only have the potential to do significant harm to individuals but also to render an entire class of drugs useless. The MCC should streamline its operations and conserve valuable resources by simply approving drugs already approved by stringent regulatory authorities.

Author: Jasson Urbach is a director of the Health Policy Unit (a division of the FMF) and of Africa Fighting Malaria. This article may be republished without prior consent but with acknowledgement to the author. The views expressed in the article are the author's and are not necessarily shared by the members of the Foundation.

FMF Feature Article / 14 December 2010