IMRAN Khan won his mandate on the promise of eliminating corruption and promoting good governance in public office. His government’s first 100 days in power are being watched closely with the expectation of a jumpstart for his promised new Pakistan. In the medicine sector, Khan is faced with daunting challenges that need bold but careful decisions to ensure a turnaround.
Let’s first put things into perspective. Essential medicines and supplies are vital tools needed to improve and maintain health. However, for too many people in Pakistan, these medicines and supplies are unaffordable, unavailable, unsafe and improperly used. An estimated one-third of the Pakistani population lacks regular access to essential drugs.
This situation does not bode well for the pharmaceutical industry, which has an annual turnover of $3.5 billion with growth approaching 13 per cent in 2016. Corruption in the sector is rampant, and implicates health providers and suppliers alike. Unfair money starts from approvals for and registration of manufacturing facilities and medical products, setting prices, quality assurance during manufacture and while in the supply chain, and goes all the way up to prescriptions written by the doctor.
The Drug Regulatory Authority of Pakistan has been dominated by persistent inadequacies and inefficiencies.
The regulatory environment under the Drug Regulatory Authority of Pakistan (Drap) has been dominated by persistent inadequacies and inefficiencies resulting in a breakdown of policy and law enforcement. There is a void between the consumers, the health sector, and the pharmaceutical industry created by mistrust.
The Drug Act of 1976 has failed to significantly impact the lack of access to quality medicines and medical supplies. Today, Drap is largely an ineffective institution. To date, there have been no official or academic evaluations of the management and performance of Drap.
Keeping in mind these complexities, three steps should be taken by the central government in the first 100 days to put the sector on its way to progress. First, start a robust good governance programme to reduce corruption in the medicines sector; second, engage stakeholders, especially the provinces, to develop a consensus on a vision and direction to take the sector forward; and third, ensure that regulatory policy and the functioning of Drap is based on scientific evidence using health technology assessment (HTA).
Good governance can prevent health-related corruption. Estimates of financial savings by controlling corruption range from 20pc to 60pc. Reducing unnecessary expenditure on medicines, using them more appropriately, and improving quality assurance could save countries up to 5pc of their health expenditures.
A Drap good-governance programme should aim to eradicate corruption in the pharmaceutical sector by developing and applying transparent and accountable administrative procedures and the promotion of ethical practices. Such a programme should also involve strengthening Drap.
At the process level, the communications media should be used to foster support for reform by influencing opinion, attitudes, and behaviour change amongst: (1) leaders and policymakers (political will), (2) mid-level bureaucrats (organisational will), and (3) citizens (public will). At the structural level, communication can link citizens, civil society, the media, and the government, forming a framework for national dialogue.
It is in this context that setting up a pharma policy think tank and communication forum could serve a fundamental role in building the momentum for reform. This think tank should be based in the national health ministry and have representation from Drap, industry, medical and pharmacy academia, the legislature, the provincial bureaucracy and technocracy, and the civil and military bureaucracy. It should be tasked with setting the medium- to long-term policy vision and direction of the pharma sector in Pakistan.
Finally, Pakistan needs evidence-based decision-making in the health and pharma sector. The current proliferation of healthcare technology and its expanding uses due to an unrelenting push by the sellers has contributed to burgeoning healthcare costs on the one side and their irrational use on the other.
The scientific discipline that makes it possible for technology to be managed around the world in ways that would improve patient access and health outcomes is called HTA. It is based on several scientific disciplines, including the pharmaceutical and health sciences, the social and natural sciences, and the humanities.
Our regulatory, scientific and academic communities have not caught the HTA wave even four decades after it started being used around the world. Now, it is time for a concerted effort to launch HTA. The evidence provided by HTA is the backbone of objective decision-making and transparency, which are so badly needed in the Pakistani healthcare system. HTA capacity is typically developed in academia, outside the regulatory agencies to avoid any potential conflict of interest.
Pakistan today desperately needs to implement a system for HTA. It could be created at the federal level and housed in an appropriate research university charged with scientifically investigating the following typical HTA questions: whether the technology works, for whom, at what cost, and how it compares with the alternatives. This will allow the health sector to make science-based choices about appropriate treatments.
In summary, the fullest potential of our pharma sector needs to be tapped with a renewed sense of purpose, direction, and seriousness. The change of government is an opportune time to bring on strategic changes aimed at medium- to long-term reforms in governance, structure, and systems across the country. These recommendations may be translated into doable and practical steps to be taken within the first 100 days of Imran Khan’s government by 1) conducting a national consultation process with all stakeholders to agree on a common vision for the sector and an ethical framework of principles fully backed by legislation and implementation mechanisms; 2) forming an HTA centre at an appropriate university; and
3) setting up a national pharma think tank to set the strategic vision of the medicines’ sector.
If they are serious about their election slogan of ‘change’, the new government will receive an overwhelmingly positive response. It is now up to Imran Khan and his cabinet to bring about the promised reform programme without wasting time.
The writer is a senior public health pharmacist.
Published in Dawn, October 1st, 2018