December 31, 2012: The Lancet and the Institute for Health Metrics and Evaluation at the University of Washington co-hosted the launch of the Global Burden of Disease, Injuries, and Risk Factors Study 2010 on December 14, 2012. The meeting featured a series of panel discussions on the subject. The fourth session of the launch, centered around comparative risk assessments was chaired by our President, Dr. Sania Nishtar. Panelists included Prof. Srinath Reddy, Sir Richard Peto, Prof. David Leon, Stephen Lim and Majid Ezzati. The podcast of the full meeting can be viewed here and for highlights of the session, you can visit the Heartfile eForum.

Published in The News International on December 29, 2012:

The brutal assassination of nine grass-roots level health workers in Pakistan, who were involved in a door-to-door immunisation campaign in an attempt to secure children from the crippling disease of polio, adds an unprecedentedly grave dimension to the ongoing carnage in Pakistan.

Pakistan’s parliament was quick in passing a unanimous resolution and there was widespread condemnation of the killings from all factions of the society – and rightly so. These incidents have deep-seated implications for the global drive to eliminate an infectious disease for a second time from the planet.

Additionally, they illustrate the nature of polarisation, mistrust and extremism that has crept into the Pakistani society, posing challenges on many fronts – beyond public health.

This tragedy comes at a time when the Independent Monitoring Board of the Global Polio Eradication Initiative had, in its November 2012 report, issued a positive note about Pakistan with regard to its efforts to curb polio.

Pakistan’s polio programme reduced cases by more than 60 percent since last year (from 154 to 64), indicating that things could turn around after the multidimensional negative trends in 2011, where environmental surveillance indicated geographically widespread transmission and domestic numbers of new polio cases kept soaring.

During the year 2011, Pakistan was also held responsible for the virus spreading beyond its borders, causing an outbreak in neighbouring western China. Additionally, it was declared the only remaining reservoir of a rare wild poliovirus type, posing a risk for reseeding Asia.

The recent wave of killings is a huge setback, placing the 2012 gains at risk. These killings have also added another level of challenges to the existing multidimensional problems for vaccination, including problems of geographical inaccessibility due to the armed insurgency in large parts of the country; refusal to vaccinate on the mistaken notion that it is forbidden by religion; population movements across the vast and porous Pak-Afghan border; abysmal state of water and sanitation; the perception that immunisation is part of a covert operation; and the 2011 commercial-interest driven smear campaign against GAVI which, despite the government’s rebuttals, helped strengthen misplaced fears about vaccination.

In fact, polio in Pakistan today is not just a public health issue, but an illustration of the problems inherent within the state and society. Pakistan’s polio eradication drive has also taken the brunt of the country’s governance challenges.

Institutionalised collusion, geared to systematic pillage at the health systems’ level and absence of an accountability law make it very difficult to insulate polio from overall inefficiencies and malpractices which plague public sector functioning. Compounding these is the 18th Amendment-led abolition of Pakistan’s Ministry of Health and the lack of readiness of some provinces.

These challenges were already overwhelming for polio eradication efforts but the recent wave of killings adds another unprecedented complexity – polio vaccination risks becoming one of the epitomes of anti-western sentiment in Pakistan. If that happens, the global gains in polio eradication could be at risk.

Much has transpired between the 1988 World Health Assembly (WHA) Resolution, which called for eradication of polio by 2012, and global events around polio eradication in 2012. During which investment of more than US$8 billion, 20 million workers and implementation in 125 countries characterises the scale of the eradication effort.

With the May 2012 WHA Resolution, labelling polio as an emergency, WHO’s Global Polio Emergency Action Plan 2012-2013, and the Endgame Strategic Plan 2013-2018 now framed, the end is in sight. But as long as a single child remains infected, children around the world are at risk.

Pakistan now has a three-fold responsibility: addressing systemic polio eradication impediments; getting vaccination back on track with appropriate security cover for more than 90,000 vaccinators; and reaching out to the masses with the right information to allay mistrust.

At a minimum this would demand the will to prioritise action, the intent and ability of political factions to work collaboratively, and the ongoing injection of resources.

The writer is the founding present of the NGO think tank, Heartfile. Email: sania@ heartfile.org

December 17, 2012: As Pakistani Drug Regulatory arrangements continue to face challenges, we publish our views on the issue and warn of a failure if systemic impediments are not appropriately addressed. Our viewpoint has simultaneously been published in the Huffington Post on December 10, 2012 and in The News International on December 05, 2012. Comments on the viewpoint are welcome through the Heartfile eForum.

Published in The News International on December 05, 2012:

The bill creating a much-needed federal drug regulatory authority – Drug Regulatory Authority of Pakistan – was enacted into law recently. The World Trade Organisation (WTO) agreements have made it 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.

On the domestic front, the 18 Amendment to the constitution omitted the entry “Drugs and medicines” along with the Concurrent Legislative List, which had earlier given provinces the mistaken notion that drug regulation could be a subnational prerogative, leading to an unnecessary year-long federal-provincial turf battle over drug regulation. 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.

Now that the authority has been created, it is time to take stock of the safeguards that need to be built to make it effective. First, independent regulation needs robust and transparent governance or it will fall prey to vested interest groups. It is also crucial that appointments are made on merit, and to ensure technical competency. 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.

Second, with respect to potential weaknesses of the new regulatory authority, the broader policy and institutional context has to be brought to bear. The authority, no matter how well resourced, technically astute and independent can 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 its ambit. The Yunani, Ayurvedic and Homeopathic Practitioners Act 1965, under which traditional and herbal medicine is dealt with in Pakistan, does not provide for regulating products. The Tibb-e-Unani, Ayurvedic, Homeopathic, Herbal and other Non-Allopathic Drugs Act, 2002 has been in the pipeline for over seven years now. The new act has also brought devices and biological substances in the regulatory net, an important step since that is an area where collusion and price gouging is pervasive.

Third, 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 human resource terms, the field force of drug inspectors is not only quantitatively paltry (250 inspectors to monitor over 600 manufacturing facilities and over 50,000 retail outlets), but also qualitatively weak. 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 that 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 incentivising pharmacists’ training. There are around 200 pharmacists in the 50,000 retail facilities as of now; 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 percent of pharmacies met licensing requirements. Only 22 percent had qualified pharmacists, 10 percent had temperature monitoring and only four percent had alternative supply of electricity for refrigerators.

A final word of caution. As the government brings the implementation arrangements of this act to fruition, they should try and separate two kinds of malfunctions which result in the creation of spurious and falsified medicines. Within this context, I would like to draw attention to a major consensus article in the British Medical Journal. The paper focuses on the question of achieving international action on falsified and substandard medicines and proposes a global treaty to address this international menace.

It also looks at a new taxonomy of medicines, one that classifies medicines into legitimate and illegitimate. The paper divides illegitimate into two further categories. One: falsified medicines – those where there has been a criminal and fraudulent intent. The second category indicates regulatory or quality failure and manifests either in unregulated or substandard medicines. To illustrate a case in point, the case of the Isotab drug disaster in Lahore was a regulatory failure of the quality assurance systems of both the manufacturer and regulator and, while not done with a criminal intent, was 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 a crime.

The new Drug Regulatory Authority presents 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. When harmful products get access to the market not only do they hurt the economy because of the black market, and hurt bona fide businesses because of infringements on their legitimate prerogatives, they also harm and kill humans. Those that stand in the way of creating transparent regulation could well be the victims one day.

The writer is the founder and president of the NGO think tank, Heartfile.