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Drug Regulatory Authority: A Case for Hope?

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The Bill "to provide for the establishment of a Drug Regulatory Authority of Pakistan" was enacted into law last week. The creation of a federal drug regulatory authority was the right decision, both in the international as well as domestic contexts. Internationally, after World Trade Organization (WTO) agreements, it has become binding on all countries to have independent drug regulatory authorities, without which key flexibilities permissible under the Doha Declaration on Public Health cannot be availed. The domestic context relates to the 18th Amendment-induced, omission of the entry " Drugs and medicines" along with the Concurrent Legislative List, which earlier gave provinces the mistaken notion that drug regulation could be a sub-national prerogative and unnecessarily led to a year-long federal-provincial turf battle over the drug regulatory mandate. Unfortunately, it was only after 125 lives were lost in the Isotab-related drug deaths in Lahore that the matter of drug regulation veered in the right direction. The instrument through which provincial assemblies ultimately conceded to the notion of federal drug regulation, a resolution under Article 144 of the Constitution, existed even when the 18th Amendment was promulgated and was highlighted in these columns on April 30, 2011 (http://www.heartfile.org/pdf/99_Mandate_to_regulate.pdf). In retrospect the lesson learnt from this experience is that decision-making should be guided by evidence, earlier on without the need for a catastrophic event to underscore its salience.

Now that the authority has been created, it is time to take stock of the safeguards that need to be built in order to make it effective. In this regard, first, it must be appreciated that desirable as it is, independent regulation needs robust and transparent governance or it is even more likely to fall prey to capture by vested interest groups than was the former Ministry of Health's-style of regulation, given that this is a highly regulated sector. It would be crucial to make appointments on merit, ensure technical competency and guarantee conflict of interest safeguards. The fact that there is a fine line between the policymaking mandate and regulatory prerogatives in this law creates all the more reason for transparency in governance. If there is a deliberate or inadvertent inattention to transparency and accountability in the governance arrangements of the authority, the consequences can be dire.

Secondly, with respect to potential weaknesses of the new regulatory authority, is the broader policy and institutional context that has to be brought to bear. The authority, no matter how well resourced, technically astute and independent--we hope all attributes will be ingrained over time--will not operate in a vacuum. Its primary purpose is to provide for "effective control and enforcement of the Drug Act, 1976", which is where there is a problem. The Drug Act has many exploitable covenants and other gaps that have emerged as a result of recent trends in technology, advertising, and WTO agreements. Moreover, traditional medicines prescribed by over 130,000 practitioners are outside of its ambit. The currently in-force Yunani, Ayurvedic and Homeopathic Practitioners Act 1965, under which traditional and herbal medicine is dealt with in Pakistan, does not provide for regulating products, a major gap. The Tibb-e-Unani, Ayurvedic, Homeopathic, Herbal and other Non-Allopathic Drugs Act, 2002 has been in the pipeline for over 7 years now and needs promulgation as a starting point to address this critical weakness. The new Act has brought devices and biological substances in the regulatory net, which is a positive and important step as they have remained outside the regulatory ambit and are an area where collusion and price gouging is pervasive. Presumably the Drug Act or another instrument will also have to be modified/updated with this in view.

Thirdly, the institutional infrastructure upon which the drug regulatory authority will be dependent for the execution of its mandate needs critical inputs to overcome existing constraints. Drug testing laboratories which are now rightly under the regulatory authority's wing need a major fiscal and technical impetus. In a human resource terms, the field force of drug inspectors on which the authority is still reliant is not only quantitatively paltry (250 inspectors to monitor over 600 manufacturing facilities and over 50,000 retail outlets!), but is also qualitatively weak in terms of capacity. Graft is the norm in regulation, both at the manufacturing and retail levels. To a certain extent, it is the grossly inadequate systems of compensation which fuel what can be labelled as 'subsistence graft'. These systemic distortions will have to be addressed by the authority as a priority. Also, innovative means will have to be adopted for implementing and incentivizing pharmacists' training. Currently there are around 200 pharmacists in the 50,000 retail facilities and the national capacity to train pharmacists will not be able to cover the gap in the next 20 years. A cross sectional survey conducted in the third largest city showed that only 19% of pharmacies met licensing requirements. Only 22% had qualified pharmacists, only 10% had temperature monitoring and only 4% alternative supply of electricity for refrigerators.

A final word of caution. As the government brings the implementation arrangements and rules of this Act to fruition, they should try and separate two kinds of malfunctions which result in the creation of spurious and falsified medicines. Such a separation is important from the regulatory and punitive perspectives. Within this context, I would like to draw attention to last week's major consensus article in the British Medical Journal with international authorship on which I happen to be a co-author. The paper is focused on the question of achieving international action on falsified and substandard medicines and proposes a global treaty to address this international menace. One of the four areas of emphasis of this paper relates to a new taxonomy of medicines, one that classifies medicines into legitimate and illegitimate. The paper divides illegitimate into two further categories; one being falsified medicines, those where there has been a criminal and fraudulent intent, such as wrong ingredients, bogus ingredients, or a deceptive design of the package. The other is the category which is indicative of regulatory or quality failure and this manifests either in unregulated or substandard medicines. To illustrate a case in point, the case of Isotab drug disaster in Lahore was a regulatory failure of the quality assurance systems of both the manufacturer and regulator and was not done with a criminal intent but serious nonetheless. Overlaps, notwithstanding, the paper recommends that the former category, "falsified", should be prosecuted by the justice system not just as civil negligence or regulatory violation but as true crimes worthy of serious punishment.

The new drug regulatory authority does present a case for hope, but if the systemic impediments and potential distortions and loopholes in the law are not addressed, it may lead to an even worse failure than what the earlier red-tape variant of drug regulation resulted in. The government must institutionalize the right checks and balances, safeguards and accountabilities. When harmful products get access to the market not only do they hurt the economy because of growth of the black market, and hurt bonafide businesses because of infringements on their legitimate prerogatives, they also harm and kill humans, and exhort significant suffering and ill health. Those that stand in the way of creating transparent regulation could well be the victims one day.