The public is still waiting for any signs of the promised first ever National Medicine Policy to appear that was due in the last week of November 2019. Special Assistant to Prime Minister on Health Services Dr. Zafar Mirza had claimed the National Medicine Policy would reform the pharmaceutical sector to deal with issues related to general public’s access to safe and quality medicines, regulatory and production issues, and human resource development.
Though delay for a month is negligible as compare to 72 years that Pakistanis spent in the absence of any medicine policy, we believe the medicine policy framework would be up early next month in letter and spirit with rationalized implementation mechanisms. Its success would all depend on how the ailing issues of the industry are addressed and what steps are proposed to genuinely get rid of the black sheep and the profiteers. Ailing patients and their relatives need only the real-time solace if the policy could deliver to win the hearts of the general public that is blemished by the high inflation and out of reach consumer goods.
Dr Zafar Mirza once pointed out that Pakistan had the highest number of per-capita injections annually – eight a year, and 90 percent of those were neither necessary nor a medical requirement for the patients. Unsafe injection practices are leading to deadly infectious diseases outbreaks as well as killing people or making them permanently disabled in Pakistan. Same is the case of unnecessary and over medication that is deteriorating the overall national health.
Easily available substandard medicines on higher rates not only add more miseries to the patients’ health but also add on monetary stress. The civil society has highlighted time again the substandard medicines production and availability in the country and drugs abuse but to no action at all. This kind of sheer profiteering needs to be monitored thoroughly and checked strictly not only by the government authorities. The government shall have too some officially recognized civil society networks to check and unearth such kind of culprits. The responsible pharma industry shall also play their role in identifying such pharma units producing the substandard and counterproductive medicines and selling on the hire rates.
Any patient may be willing to pay more for the quality medicines if ensured rationalized treatment. The nexus of profiteering pharm units and the medical practitioners shall not take the advantage of ailing people. Hopefully the national medicine policy would come up with a strong mechanism to check such kind of exploitation. The pharma industry shall also take up the public education and information initiative on rationalized medication and preventive measures as well as on the adverse reactions of drugs. In the absence of pharmacovigilance system, we have no clue to several other harmful reactions due to irrational use of medicines, and we totally unaware of a serious risks involved thereof. Another issue is self-medication. Anyone can get any medicine without any prescription by the registered and certified medical practitioner. The people use drugs as they are sweet candies or chocolates. But they are not, and the irrationally used medicines could have worst reaction immediately or in the long-run. But the general public has no awareness on the rational use of medicines. The substandard and irrationally high potency medicines are available on the pharmacy shops as the children could buy their favorite sweets.
Generally, people are very fond of using high potency drugs on their own. While the experts believe that the general public needed to be taught that except for a few over the counter drugs, majority of drugs can kill them, make them permanently disabled and ruin their lives. So, the safe use of medication is an integral part of an effective healthcare system to cure and prevent diseases. Therefore, the assessment, understanding, and prevention of adverse effects or any other drug-related problem made the foundation of pharmacovigilance that is being taken globally and nationally on urgency as it directly correlate patient safety. It is the missing link in our healthcare system that needs immediate remedial. Though DRAP has recently published some guidelines on pharmacovigilance, it needs to have comprehensive campaign to engage stakeholders and to educate general public.
People are very fond of using high potency drugs on their own. While the experts believe that the general public needed to be taught that except for a few over the counter drugs, majority of drugs can kill them, make them permanently disabled and ruin their lives
While envisioning the first National Medicine Policy, a well-know pharma expert Arshad Rahim Khan suggests that the manufacturing and supply chain of the pharmaceutical industry to be upgraded to meet the standards of the Drugs Act 1976 and its various amendments and addendum from time to time. For this a risk-based, tiered approach should be adopted. Special incentives should be provided to companies that want to go beyond this level of compliance and target export markets. If a company achieves higher level of compliance then they should be given preference in the local market as well in government and institutional business.
Capacity building within DRAP to support this policy needs to be undertaken. A comprehensive and extensive training and development program needs to be prepared and implemented. Perhaps a training academy needs to be set up with a defined curriculum. In this regard, the experts have advised the government to study the mechanisms being implemented in the region especially the regulatory frameworks of the Malaysian or Vietnam FDAs.
Digitization of the whole sector should be envisioned from the manufacturing supply chain as well as from the regulatory point of view. The present low-level, low-quality set-up should be totally revamped to cater to the needs of the future. This should include the track and trace component as well.
Undoubtedly, the National Medicine Policy is welcome step of the government, but the question is that which authority will be responsible to implement it? Will it be DRAP or a separate cell working within the DRAP would be responsible to implement the framework within certain timelines and given parameters and updating it in future as per changing needs?
Regarding the purchasing and supply mechanism of essential medicines, will there be a central coordination and management body to carry the task or any other mechanism would be adopted? Will the NMP come up with any framework of a process to encourage industry-academia collaboration to promote Research and Development (R&D) in the relevant areas of new formulations, APIs and manufacturing of excipients (chemical industry)? Most importantly, will the forthcoming medicine policy would be able to address the challenges of quality, availability, accessibility and affordability for the general public? We all shall wait for a few more weeks to have the answers.
The writer is the Director Devcom-Pakistan, an Islamabad-based policy advocacy, strategic communication and outreach consulting