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Flaws in drug law

October 30, 2012

THE passage of the long-stalled Drugs Regulatory Authority of Pakistan (DRAP) Bill through both houses of parliament within days of each other is only to be welcomed. Yet the hasty manner in which the bill was hurried through poses important questions about the bill’s timing and context.

The demand for a national drugs regulatory authority has been on the agenda since 2005 when the federal cabinet gave the nod to its formation. Since then, a tussle has been waged among various stakeholders over its composition, jurisdiction and functions. This ongoing discussion was given new urgency by the passage of the 18th Amendment which devolved drugs and medicine to provincial governments. However, the area of drugs’ regulation was thought fit to be reverted to a national mandate.

As a result, in February, a national drugs regulatory ordinance was proclaimed, giving it legal cover. Between the promulgation of the ordinance and the passage of the bill, noisy and insistent demands were heard from the pharmaceutical industry calling to regularise the ordinance. This led to the provinces passing a resolution authorising the federal government to legislate on drugs’ regulation so that a single policy across all provinces could be harmonised.

The recently passed bill fulfils this requirement. However, there was much toing and froing between different interests in the run-up to its passage, which showed up in three different drafts jostling for favourable placement in the final document. Press reports regarding the purpose and composition of DRAP raise serious questions.

DRAP is envisaged as regulating the import, manufacture, storage, licensing, registration and pricing of therapeutic drugs and medical devices in line with the Drugs Act 1976. However, unlike other national regulatory authorities, the language of the ordinance — which appears to be reflected in the bill — is very mechanical and does not set great store by public protection.

As such, not much is available by way of mechanisms on how to ensure the safety, quality and affordability of medicines, which is the major public health challenge facing Pakistan. The overwhelming emphasis seems to be on the pharmaceutical industry rather than on preventing the public from being exposed to unsafe or substandard drugs.

In line with this thinking no wider consultation involving civil society and citizen watchdog groups seems to have been conducted. Besides failing to prioritise drug safety and affordability, DRAP also lists the promotion of the export potential of the pharmaceutical industry as one of its functions. This should not, however, quite fall into DRAP functions as evidenced in the role played by such bodies worldwide. There is a danger here that DRAP might become an expo centre for the pharmaceutical industry. This constitutes a distraction from DRAP’s core functions.

Giving DRAP adequate and sustainable resources lies at the root of its viability, effectiveness and independence. Currently, its sources for funding are pretty uncertain. The federal government is to chip in with initial seed money that is to be supplemented with money from donors and other grants-disbursing international organisations. With such an uncertain funding base, what expectation can we entertain of DRAP being autonomous and independent? More importantly, with uncertain funding, it would be a tall order to field an enhanced enforcement force that is crucial to the functioning and legitimacy of the new authority.

The composition of DRAP is also lopsided in terms of being representative. Its policy board is composed of representatives from key ministries, the provinces and six experts to be drawn from the public and private sectors. While suspending judgment over what value government-appointed bureaucratic nominees are going to add to the supposedly independent functioning of DRAP, one is tempted to inquire about the selection of six other members, most of whom are to be drawn from the pharmaceutical industry with a sprinkling of public-health specialists. There are suggestions that one member may be from the army medical corps.

This is quite a lopsided selection as it does not include any representative from a wide array of patients’, health-rights research and advocacy bodies, consumer groups and citizens’ bodies that are overwhelmingly affected by the new legislation. Moreover, any inclusion of a member from the army medical corps would be unnecessary. If such a suggestion has been triggered by the recent ephedrine scandal, there are many ways to address it. Similarly, there is no clarity on the fate of drugs registration and licensing boards which used to decide on registering and licensing new medicines. Will these bodies be disbanded and their functions transferred to DRAP? My own sense is that DRAP will take over these functions. One indication of this comes from news reports of the pharmaceutical industry pushing DRAP to rush through 14,000 pending applications for new drugs.

Given that drugs licensing and registration procedures are riddled with irregularities, as shown in the recent scandals over the hasty and under-scrutinised approval of thousands of medicines in a single sitting, DRAP should not feel pressured. It should institute proper procedures, as is the case in other countries, with a view to determining the safety, quality and affordability of new, applied-for-registration drugs before waving them through.

DRAP should also focus on bringing traditional medicines, currently outside the purview of 1976 Drugs Act, into the registration net. One example of how DRAP can improve its wider role — apart from some of the criticism above — is by revisiting the Indian parliament’s 59th report of the parliamentary standing committee on health and family welfare. This concerns the functioning of the central drugs standard control organisation.

By getting it right this time, DRAP can avoid policy failures which kept similar initiatives hamstrung in the past.

The writer is an Islamabad-based development consultant and policy analyst.