It goes without saying that Pakistan’s healthcare sector faces myriad governance challenges — a weak regulatory enforcement mechanism allowing substandard medicines to be marketed; the proliferation of inadequately trained or unlicensed healthcare providers (quacks) in the absence of a strong inspection or complaints system; and a general lack of awareness when it comes to patients simply knowing their rights in a bureaucratic system that is designed to be overly complicated, to name a few. Amid all this, there is the issue of unethical practices, whereby healthcare is driven not by quality patient-care but the need to drive up profits. So where do you even begin to untangle the mess? This was the topic of discussion at the first-ever forum that brought together stakeholders like the Drug Regulatory Authority of Pakistan (DRAP), Pakistan Medical and Dental Council, Healthcare Commissions, representatives of pharma companies’ and medical practitioners to discuss and “develop a practical roadmap” to address some of the challenges posed by unethical practices in the healthcare sector. Addressing the gathering, Justice (retd) Zia Perwez said that “Any attempt at reforming healthcare should not be a state-led process alone. It must include the voices of healthcare professionals and other concerned stakeholders.” Justice (retd) Perwez, who currently chairs Transparency International Pakistan (TIP), made these remarks at the High-Level Forum on Good Governance and Ethical Practices in the Medical and Pharmaceutical Sector in Pakistan, held at Marriott Islamabad on Monday. The event was co-organised by Transparency International Pakistan (TI Pakistan) and PatientsNotProfits, an initiative of the London School of Hygiene & Tropical Medicine (LSHTM) and AKU. DRAP CEO Dr Obaidullah, one of the keynote speakers at the event, minced no words when he admitted that governance has always been a challenge for lower middle income countries like Pakistan. “The very idea of establishing entities such as the DRAP and the respective healthcare commissions was that they would work differently from govt bureaucratic culture,” he said, adding that these regulatory bodies have three basic functions: ● Service delivery ● Building confidence in government, which wants them to function optimally ● Provision of all resources with transparency, accountability and ethics The DRAP, according to Dr Obaidullah, is responsible for the provision for the “safety, efficacy and quality of medicines in the country,” he said. “But ethics is built into our role; and when you talk about healthcare delivery, it is important to talk about ethical considerations.” Evidence on rampant unethical medical practice was at the heart of the discussion at the forum, whose inception was grounded in a research paper published by researchers at the London School of Hygiene and Tropical Medical (LSHTM) and the Aga Khan University in Karachi. Prof Mishal Khan, one of the lead researchers on the project and an organiser with PatientsnotProfits, highlighted that the research study showed that “… 40% of doctors in Karachi took a bribe from sales representatives affiliated with a company that was completely fictitious — without any knowledge of the company or quality of medicines, doctors were willing to take it up just on the basis of monetary benefits.” Based on the research Prof Khan, along with TI Pakistan’s Kashif Ali, suggested several policy recommendations that could help address some of these unethical practices: – Standardized curriculum covering health regulations and ethical practice – Mandatory Continuing Medical Education – required for relicensing – Mandatory training of pharmaceutical company staff, with an emphasis on ethical marketing practices – Establishment of a fair procedure for healthcare complaints – Mandatory public reporting by pharmaceutical companies – Reporting of actions taken by regulators – Essential capacity for, and functioning of, DRAP – Enforcement of rules on reporting of pharmaceutical marketing spend – Reporting on action taken against substandard drugs – Strengthening nutraceutical regulation The recommendations were then put to the test before a panel comprising various stakeholders in the healthcare sector — Prof. Dr. Rizwan Taj, president of Pakistan Medical and Dental Council (PMDC); Zeeshan Nazir, Director, QA< and Biological Divisions at the Drap; Dr. Osman Waheed, Central Executive Committee member of the Pakistan Pharmaceutical Manufacturers’ Association (PPMA) and Dr Aamir Jafarey – professor at the Centre for Biomedical Ethics and Culture, SIUT. The panel was moderated by Prof Dr Sameen Siddiqi, chair of the Department of Community Health Sciences at the AKUH. Setting the stage for an engaging discussion, Dr Sameen Sddiqui kicked off the panel discussion by acknowledging that the research paper published by Dr Mishal Khan’s team was a landmark publication. “It’s not easy to conduct a study of this nature in any country,” he said. The paper has found that “40% of our physicians are engaged in unethical practices.” “How can we collectively address this stubborn issue?” he asked, giving the floor to Dr Rizwan Taj. Dr Taj, who took over the PMDC’s reins just over two years ago, said that one of the first tasks for him was to ensure that medical education in Pakistan complied with the World Federation of Medical Education standards. “We accomplished this in a record seven months,” he said, adding that this also includes bioethics. He confirmed the commitment to make continuing medical education (CME) mandatory for relicensing within 6-12 months. “At the moment we have 400,000 doctors registered,” said Dr Taj. “We will link relicensing with continuing medical education,” he explained. PMDC was urged to do even more though, including collaboration with Pakistani experts in medical ethics. According to Dr Jafarey, it is crucial that the PMDC recognise bioethics as a “separate entity”. “There must be a structured approach to developing bioethics as a department,” he said, adding that you would then be teaching guidelines so your physicians have the training required to distinguish between right and wrong. His remarks were met with nods from the room, many of whom had earlier expressed similar thoughts. On the pharma side, Waheed, who represented the PPMA, said that the association was optimistic about the enforcement of ethical practices, because it was in everyone’s interest. “The challenge is that we have 250 members, while there are a total of 650 pharma companies,” he said, adding that unless there was buy-in from everyone or strict enforcement, there wouldn’t be impactful change. For its part, said Waheed, the PPMA has decided to set up an ethics committee, which would also provide training material and workshops for its member companies on ethical marketing practices. To a question on whether self-regulation was possible for pharma companies, Waheed explained the PPMA membership was voluntary, hence “so is compliance”. He added, however, that the association was willing to work with other stakeholders including the PDMA and DRAP to develop and deliver workshops on ethical practices in medical colleges as well on ethical marketing for pharma representatives. The second panel was moderated by TI Pakistan’s Kashif Ali and featured Dr Zainab Hasan, Director of Clinical Governance and Training at the Sindh Healthcare Commission, Ayesha Tammy Haq, Executive Director at the Pharma Bureau [a representative body of multinational pharmaceuticals in Pakistan]; Dr Noor Muhammad Shah, director of Drap’s licensing division; and Dr Shahzad Ali Khan, Vice Chancellor of the Health Services Academy. Opening the session, Ali asked the Drap’s Dr Shah how the regulator could perform its role more effectively. In response, Dr Shah explained that ever since its inception in 2012, the Drap had come a long way — it has undergone digitisation and almost gone paperless; it has rigorously adopted global benchmarks etc. “Our biggest challenge is human resource,” he said. “If more resources are made available, we can move forward in a much better way.” For the SHCC’s Dr Zainab, one of the biggest issues when it comes to the enforcement of regulations is the lack of public awareness. “We receive plenty of complaints, but there have been hardly any on over-prescribing or unnecessary medical tests,” she said. Moreover, “many of the persons who are engaged in over-prescriptions aren’t even doctors … they are quacks,” she added. At the SHCC, we are big advocates for ethical practices,” said Dr Zainab. “We even collaborated with Dr Mishal and her team on their research study and there was lots of learning for us.” But, Dr Zainab added, “the commission has a very specific domain. We can’t do it alone. We need to collectively address this challenge and develop a unified framework with very specific instructions for all stakeholders.” “In the end, we all want safe, quality patient care.” For the Pharma Bureau’s Haq, the issue of unethical marketing practices cannot be addressed until there is implementation of existing rules and regulations across the board. “The 10% limit on ethical marketing should be applied on everyone,” she said, adding that “pharma companies are not philanthropists … They are there to make a profit.” However, she added, “you don’t need to make 10,000% profit.. But you need enough profit to be able to sustain and also fund research and development,” pointing to the Central Research Fund that is collected by Drap since 1978, but which has not been used even once. Responding to her comment later, the Drap CEO clarified that the regulator had advertised a call for proposals six months ago and had hardly attracted any interest. “We cannot expect Pakistan to develop a new drug in the next 10 years, but at least we can have local research to identify systemic issues and ways to address them,” he stressed. For Dr Shahzad Ali Khan, the VC of the Health Services Academy, there must be a buy-in from all stakeholders if there is to be improvement in service delivery in the healthcare sector. “The govt alone cannot provide services to the entire population. You need the private sector to work with the government.” He added, however, that the current model of governance, whereby “politicians raid public hospitals and demean doctors” is counter-productive. “You need to develop stringent accountability mechanisms that hold accountable those actually responsible, not the scapegoat at the lower rungs,” he stressed. In the end, all participants agreed that stakeholders would have to work in tandem with each other if public trust in the healthcare sector is to be restored. This can only happen when there is “accountability, transparency and participation” from all stakeholders with a pledge to weed out unethical practices. Demonstrating their commitment, participants agreed to a formalised working group with clear roles to take forward the conversation under the umbrella of Drap.
