Regulator’s tardiness in approving medicines is hurting the industry and patients

One of the most frustrating problems that has plagued the SA pharmaceutical landscape for at least the last decade is the inability of the country’s drug regulator to approve medicines timeously.

The regulator can take more than six years to approve a drug that often has already been approved by an advanced-country drug regulator. This tardy process has resulted in a backlog of about 16,000 drugs awaiting marketing approval.

Not only do these delays reduce revenues and increase costs to drug makers, they also deny and retard patients’ timely access to the medicines.

Though some people may consider it necessary to have a local regulator to ensure products are safe, bureaucratic inertia is denying thousands of SA patients access to medicines that have already been approved elsewhere that could cure or manage their symptoms.

For cancer and HIV patients, these delays could be fatal.

About half of the drugs awaiting approval are for new registrations of medicines that are in use overseas. Half of these drugs have been on the marketing approval waiting list for more than five years. One drug manufacturer says it has waited up to seven years for a regulatory decision on some of its products and has more than 250 dossiers awaiting approval.

If a drug is not registered with SA’s drug regulator, the SA Health Products Regulatory Authority, the patient can sometimes gain access to it through a Section 21 permit, which allows them to import it from overseas. This is a costly process since medical aids will not reimburse a patient for an unregistered medication.

Though it may come as some relief to patients who can afford the drug through out-of-pocket payments, it fails to address the underlying cause of why patients are not gaining access to drugs timeously 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. The reform led to the regulator being overwhelmed by registration applications from generics manufacturers, a process that continues. This policy must be scrapped urgently.

It is encouraging to note that the chair of the board of SA’s drug regulator, 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 US Food and Drug Authority (FDA) or its EU equivalent, the European Medicines Agency (EMA), before market authorisation. Manufacturers typically then register in smaller markets such as SA.

Pharmaceutical powerhouses

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. Singapore is consequently one of the top medical tourism destinations.

If it had not adopted this approach, it is unlikely 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 in and setting up manufacturing plants in a country where they face 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 policymakers in some countries, such as rising pharmaceutical powerhouses Singapore and Ireland.

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

• Urbach is an economist and Free Market Foundation director.

This article was first published on BDLive on 01 July 2019.
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