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Healthcare stands on three pillars: Healthcare related policies; Public and private health infrastructure; and availability of diagnostic and treatment tools, the last one also includes easy access to drugs. We shall review each of these in some detail to understand the entire healthcare landscape. The information is gathered from several sources, and references are given at the bottom.
Drugs & Devices Infrastructure
Access to Drugs
Pakistan boasts a large pharmaceutical industry which helps the patients to have easy access to drugs and at reasonable prices. Most medicines can be found everywhere in the country; some specialized ones are available more selectively. We have rather loose, uncontrolled system where almost every medicine can be bought over the counter without a prescription.
Availability of medicines in the public hospitals is the responsibility of government, who has experimented with various methods to combat corruption in purchase and pilferage from hospitals but has never been successful. In fact, the rate of underhand dealing has only increased with every change in the system. 40-50 years ago, provincial governments maintained a central store of medicines which was also responsible for central purchase. All major companies competed in the bidding process because it was fair, and a nominal percentage had to be paid at one point only. The central store collected demand from all users at district and tehsil level, floated tenders, purchased drugs, and distributed as per demand. Sometimes they purchased brands which were different from the ones demanded and it made the users unhappy. They also felt that almost their entire budget was consumed by the central store, and they did not have the leverage/advantage to do purchases. Due to their pressure, first phase of decentralization took place. During Musharraf era, the procurement was almost totally decentralized. This led to a massive wave of corruption which lasted until some reversal took place. Presently, the purchase is more or less balanced between centralized and decentralized portions. It must be mentioned that due to all these experiments, major companies were forced to abandon bidding in government purchase, and the arena was left open for smaller players who connived with purchasers to replace major brands with small, unknown brands. We already know for sure that every new regulation opens new window for corruption, if not a new window, then at least the rate of underhand dealing increases.
According to reports, patients in public hospitals may have to spend up to 78% from out of pocket despite the fact that public hospitals are supposed to be free.
Access to essential medicines is recognized as part of the fulfillment of the right to health in Pakistan’s national constitution. Pakistan has fairly well-developed policies, acts, and operative guidelines. The Drug Act 1976 regulates the pharmaceutical sector setting out extensive stipulations for industry licensing, drug registration and quality control. However, the Drug Act of Pakistan has neither been updated with the international World Trade Organization’s (WTO) statutes nor with local stipulations such as the Pakistan’s Patent Ordinance of 2000. A National Medicines Policy was developed in 1993 and again in 1997 but did not have a strategic plan for implementation.
In the study referred to at the end, a synthesis of evidence found major gaps in essential medicine access in Pakistan driven by weaknesses in the health care system as well as weak pharmaceutical regulation.
Pharmaceutical industry is among the major industries of Pakistan, owing to the volume of business it generates, the number of people it employs, and the services it provides by way of keeping the drugs available at rather affordable prices in every corner of the country. Pharmaceutical industry is among the most regulated industries, as is the case all over the world, due to the sensitivity of public health concern. Patients may suffer unnecessarily due to one of the three reasons: negligence of doctors and paramedical staff in diagnosis; administration of wrong drugs; and poor-quality drugs. The first two variables are overseen by the health commission whose working is not shared with public generally. It is not known if they have enough capacity to visit all government and private hospitals. The third one, drugs, are the responsibility of DRAP – Drug Regulatory Authority Pakistan.
Quality of Drugs
Much has been said and written about the quality of drugs in Pakistan. The case of counterfeit medicines and spurious drugs keeps appearing in talks, and some people even claim that 80% drugs on Pakistan market are spurious or counterfeit (counterfeit looks like the original but is not; spurious is of substandard quality). This claim is absolutely without evidence. There is an elaborate structure for monitoring quality of drugs at manufacturing stage, at the distributors, and at the retail pharmacies.
There is a presence of counterfeit and spurious drugs on the market, but it is relatively small scale, patchy and inconsistent. It should be understood that no drug can be manufactured in the backyard of a house, because it requires machinery and equipment to manufacture drugs. Printing of packaging material is another obstacle because of its specialized nature. This leads us to the conclusion that some licensed manufacturers are likely involved in this criminal business. Given the lax regulatory system, this can happen, and the blame goes directly to DRAP which is responsible for ensuring availability of quality drugs. Sometimes, a team of some health authority along with media teams inspect some factory and report huge caches of spurious or counterfeit drugs. After the media hype for a day or two, the case is forgotten. No one sees any indictment, much less conviction in such cases. There can only be two possibilities: one, the case is closed after receiving hush-money; or the charges were fabricated.
There are three factors which may be compounding the issue of fake/counterfeit/spurious drugs. One, DRAP is still renewing licenses of very old manufacturing units which do not comply with the cGMP – current Good Manufacturing Practices guidelines. These companies have scarce resources because their business is small scale. They may indulge in malpractices to survive. Two, DRAP does not differentiate between poor and excellent companies while registering and pricing the drugs. The good, the bad, the ugly, get the same treatment. Three, DRAP still does not encourage separation of marketing and manufacturing companies. Entrepreneurs are compelled to have a manufacturing unit, even a small one, to avail benefits like ownership of registrations, import of materials etc. If DRAP changes its policies and tightens its regulators, the quality issues can be largely addressed.
The biggest grey area is alternative medicines such as herbal drugs, phytopharmaceuticals, nutraceuticals, and supplements. Until the promulgation of OTC & Healthcare policy in 2014, this business was completely unregulated. People manufactured bad quality products in shabby conditions, packaged these nicely, and sold at exorbitant prices. After the new policy, DRAP has been issuing provisional enlistment certificates to these drugs without really examining their formulations. Unlike pharmaceuticals, the prices are unregulated, and most manufacturers are fleecing the patients in connivance with the prescribing physicians. An overhaul of this part is desired to differentiate between serious, quality conscious manufacturers and poor ones. Prices should also be rationalized and controlled.
Medical devices are small devices which may be disposable or reusable. Disposable syringes, gloves, masks, infusion sets, transfusion sets, blood bags, butterfly needles, cannulas, and blood lines are some of the medical devices. For a long time, medical devices business was completely unregulated. Anyone could import or manufacture and start selling, but then gradually more and more products were taken under medical devices. This has improved control over the business, but problems of quality exist.
Internationally, products like inhalers, aerosols, several products for burns, are registered as medical devices, but DRAP registers these as drugs, not medical devices. This causes problem for international suppliers because they cannot provide documentation required for drug registration. A change in policy is desired.
In the next post, we shall sum up and conclude the topic of state of healthcare in Pakistan.
To be Concluded……
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deb_pone.0063515 1..10 (plos.org)
Primary health care strengthening and health financing reforms – a priority for the federal and provincial governments in Pakistan (who.int)