Not business as usual
Regulation in Pakistan simply means bureaucratic hurdles, excessive paperwork and creating a culture of frustration
The writer is a Howard Hughes Medical Institute professor of biomedical engineering, international health and medicine at Boston University. He tweets @mhzaman
The last few weeks have laid bare the deep cracks that continue to suck the vulnerable. The unacceptable rise of HIV patients in Larkana, the passing of Nashwa in Karachi and even the traffic tragedy that took the life of Usama Qamar, the young son of Qamar Zaman Kaira, have one thing in common. It is the complete breakdown of the national regulatory sector that aims to protect consumers. Whether it is the presence of substandard vaccines and therapeutics given to vulnerable patients, the prevalence of used needles and clinical malpractice, or the lack of airbags to save lives — there is an underlying theme here of a weak and inefficient regulatory sector.
There are two major issues with the poor regulatory sector in Pakistan. First, some of the above mentioned issues are already resolved in many other countries, and we do not need to reinvent the wheel. The drug and vaccine quality issue — one that has been a centre of my own research for the last decade — requires closing loopholes in procurement, improving pre- and post-market surveillance and creating stronger penalties for those who do not comply. Those who engage in endangering the lives of patients should face consequences. These are crimes against the public and not just one individual. Out of court settlements, as happened in the case with Nashwa, should not be even an option. DRAP has been too busy in fighting battles on drug pricing and has been completely missing in action when it comes to enforcing standards of drug quality. The same goes for widespread use of contaminated needles and quackery. Airbags, invented nearly seven decades ago, are also a standard requirement in modern cars. In the US, the federal government required all passenger vehicles to have dual frontal airbags in 1998. Similar laws have been enacted, and enforced, in countries around the world. In Pakistan, the debate has gone on for several years in parliament and courts, but car companies are able to get away without having effective and working airbags. The government has remained impotent, and the general public has paid a heavy price, often through their lives.
The second issue is with the culture of regulation. Regulation in Pakistan simply means bureaucratic hurdles, excessive paperwork and creating a culture of frustration for the business community. Ask an entrepreneur about his or her experience dealing with the regulatory sector in Pakistan and they would have an endless list of complaints about excessive mind-numbing paperwork, rules that are archaic and applied inconsistently and an attitude by regulators who think of themselves as demigods. And this is not even accounting for our longstanding corruption issues.
The solution to effective consumer protecting regulation comes from both a top-down (effective and enforceable legislation and enactment) and a bottom-up (awareness and public demand) approach. The top-down approach continues to be a problem. Parliament has been woefully ineffective in creating consumer-oriented regulation. Worse, if recent history is to be taken as an example, members of all parties have shown their allegiance to inertia and customs than caring for the weak and the vulnerable.
There is, however, a bit more hope in the awareness side of the equation. Recent campaigns to bring the issues to the fore about HIV, substandard medicines and car safety have gotten the attention of talk show hosts and journalists but successful campaigns require sustained efforts. These events cannot be overshadowed by another event that takes our attention and energy away from consumer protection. Civil society groups have to make a case to demand quality and regulation for public safety.
Safety ultimately is both a collective right and a collective responsibility. We only get to enjoy it as a right if we demand it as a responsibility to ourselves and others in the society.
Published in The Express Tribune, May 28th, 2019.
There are two major issues with the poor regulatory sector in Pakistan. First, some of the above mentioned issues are already resolved in many other countries, and we do not need to reinvent the wheel. The drug and vaccine quality issue — one that has been a centre of my own research for the last decade — requires closing loopholes in procurement, improving pre- and post-market surveillance and creating stronger penalties for those who do not comply. Those who engage in endangering the lives of patients should face consequences. These are crimes against the public and not just one individual. Out of court settlements, as happened in the case with Nashwa, should not be even an option. DRAP has been too busy in fighting battles on drug pricing and has been completely missing in action when it comes to enforcing standards of drug quality. The same goes for widespread use of contaminated needles and quackery. Airbags, invented nearly seven decades ago, are also a standard requirement in modern cars. In the US, the federal government required all passenger vehicles to have dual frontal airbags in 1998. Similar laws have been enacted, and enforced, in countries around the world. In Pakistan, the debate has gone on for several years in parliament and courts, but car companies are able to get away without having effective and working airbags. The government has remained impotent, and the general public has paid a heavy price, often through their lives.
The second issue is with the culture of regulation. Regulation in Pakistan simply means bureaucratic hurdles, excessive paperwork and creating a culture of frustration for the business community. Ask an entrepreneur about his or her experience dealing with the regulatory sector in Pakistan and they would have an endless list of complaints about excessive mind-numbing paperwork, rules that are archaic and applied inconsistently and an attitude by regulators who think of themselves as demigods. And this is not even accounting for our longstanding corruption issues.
The solution to effective consumer protecting regulation comes from both a top-down (effective and enforceable legislation and enactment) and a bottom-up (awareness and public demand) approach. The top-down approach continues to be a problem. Parliament has been woefully ineffective in creating consumer-oriented regulation. Worse, if recent history is to be taken as an example, members of all parties have shown their allegiance to inertia and customs than caring for the weak and the vulnerable.
There is, however, a bit more hope in the awareness side of the equation. Recent campaigns to bring the issues to the fore about HIV, substandard medicines and car safety have gotten the attention of talk show hosts and journalists but successful campaigns require sustained efforts. These events cannot be overshadowed by another event that takes our attention and energy away from consumer protection. Civil society groups have to make a case to demand quality and regulation for public safety.
Safety ultimately is both a collective right and a collective responsibility. We only get to enjoy it as a right if we demand it as a responsibility to ourselves and others in the society.
Published in The Express Tribune, May 28th, 2019.