Healthy Skepticism Library item: 7589

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Publication type: report

Babar Z
Medicalising Pakistan
: Chowk 2007 Jan 8
http://www.chowk.com/show_article.cgi?aid=00007533&channel=university%25

Abstract:

Flourishing Pharmaceutical Industry & the Rising Concerns of Public Health

A recent visit to Pakistan was the eye opening one. There was one pharmacy in my neighborhood a few years ago, but now the small street is sprawling with five pharmacies and all are doing “wonderful business”. This is happening almost everywhere in the country, more and more people, non-professional or professional, illiterate or literate, everybody is jumping into this bandwagon because the business is lucrative and the profits are huge. As the population is growing and there are issues of poor housing, lack of exercise, pollution, improper diet and the lack of health education, diseases are rampant. In this situation, drugs are considered panacea for every ill and even prescribed for malnutrition.

The days have gone when providing affordable medicines to the needy was considered a noble deed; now pharmacy owners hate customers with few drugs and rather would like to see a long list of medicines on a prescription. Self-medication is widely practiced; in majority cases, unqualified practitioners, by whom actually person’s existing health is deteriorated, dispense drugs. For sure, within this environment, National Medicine Policy is not working and country’s policy makers are still debating the draft of upcoming drug regulatory authority [1]. Let’s look what is the government’s prescription for the problematic pharmaceutical situation?

The Government’s Stand and the Development of Pakistan’s Pharmaceutical Industry

In 1993 there were 256 national pharmaceutical units and 38 Multinational Companies (MNCs), however, since 1999 the government has invested US$ 133 million in the pharmaceutical industry and now there are 411 local companies while 30 MNCs [2, 3]. The current market is more than US $1billion and there are approximately 63,000 pharmacies in the country [4, 5].

Though, in recent years, exports of most of the middle-income countries were on the lower side, Pakistan exports more than doubled, from 1.1% to 2.9% during 1980-1999 to various Middle Eastern and African Countries [6]. Pakistan exported drugs worth 37.5 million US dollars in 2000-2001, fifty million US dollars in 2004 and 65 million US dollars in 2005 [7, 8, 9]. The Ministry of Commerce has given 50% subsidy to pharmaceutical companies for registration of their exported products in foreign countries for export from 1998 to 2003 [10]. In 2005, the Ministry of Commerce provided funds to the pharmaceutical exporters for the salaries of 3 medical representatives for a period of 2 years @ US$ 500 per medical representative per month [11]. While addressing United States chamber of commerce and industry, Prime Minister Shaukat Aziz said that the pharmaceutical industry in Pakistan is flourishing and exporting millions of dollars worth of medicines each year [12].

The government’s objectives are clear: increase the number of pharmaceutical companies, increase exports, achieve self-sufficiency and earn foreign exchange. A very simple and pragmatic approach but this needs a careful evaluation especially when Pakistan’s drug regulatory structure is on the verge of annihilation. In case of increased production, a small number of medicines may be exported while a large sum is still consumed within the country. So the question arises; is there any relationship between the government’s pro industrial policy and the increasing irrational drug usage in the country? Are policy makers aware of the issues related to safety, efficacy or rational drug usage or promoting exports considered sufficient to address drug use problems?

Safety, effectiveness and quality of medicines versus Government’s pro-industrial policy

Though there is no systematic study, which evaluates the government’s pro-industrial policy and its effect on improving use of medicines, however documented evidence shows an overall dismal situation. Government policies seem to have affected little to improve rational drug use and the pharmaceutical market is saturated with surplus and “me-too” products [13]. There are 28000 registered drugs in the country of which 70% are unnecessary or harmful [14, 15]. For an individual molecule, dozens of different brands are registered in the country as in the case of ofloxacin where 34 brands were found with doubtful effectiveness and safety [16].

With increased production of medicines, there are more chances of aggressive marketing as seventy percent of patients in Pakistan are treated with antibiotics, although the majority of them don’t need these medicines [17]. A significant portion of medicine is also wasted owing to incorrect dispensing practices [14]. A recent study shows that unethical and biased claims regarding medicinal products are rampant in Pakistan [18]. There is no mechanism to monitor drug promotional campaigns by the pharmaceutical industry [18]. Narcotics, psychotropics, antibiotics and hormonal drugs are freely available without prescription and a study in one of the districts showed that only 19% of the pharmacies meet the licensing requirement [19]. Industry is only interested in producing profitable medicines and there is a severe shortage of essential drugs in the country [20].

Increased production of medicines also does not automatically guarantee universal access to medicines. As a result of non-availability of drugs at government hospitals, Pakistanis spend 77% of their healthcare budgets buying medicines [6]. The government is also facing severe criticism because of the widespread availability of sub-standard drugs in the country [21, 22].

Indeed pharmaceutical industry is important for the country’s healthcare but one has to be cautious if the industry is also heavily involved in corrupting medical practice. The link between weak implementation of medicine policy and irrational drug usage is obvious as it strengthens the economic goals of the pharmaceutical industry. In result of that, it increases the sale of drugs and reduces any attention to proper education and information and monitoring of drug safety and efficacy. This also prevents the growing of a public health system of independent information and decision-making and doctors and pharmacists are overwhelmed and unable or unwilling to exercise their professional responsibly to patients and to themselves.

The Tale of Conflicting Interests between Drug Policy and Industrial Policy
The role of a drug regulatory authority is to execute the functions, which are stipulated in drug laws of the country while national drug policies provide the framework to establish safe, effective and quality use of medicines. Let’s see how this has been dealt within in Pakistan.

In 1996, a comprehensive National Drug Policy was drafted with the objectives of the mandatory production of essential drugs [23]. However at the time of implementation, it was opposed by the pharmaceutical industry, policy was revised and mandatory supply of essential drugs, which was not in the economic interest of the industry, was dropped from the policy [23]. Now, ten years down the road, there is another policy in place and according to critics, it is full of ambitious, incoherent and non-committal plans and has a clear tilt towards the industry [24, 25]. There is no detailed planning how the policy would be implemented? Also, it does not state that how would it deal with competing interests as promoting drug exports and the concept of the rational use of drugs; these two objectives of NDP are conflicting in nature. Policy makers do not have the capability to analyze and overcome these issues and the current NDP on Ministry of Health’s website clearly states that it is in fragmented form, and to meet the challenges; a more comprehensive drug policy is required [25].

These conflicting interests between industrial support and pharmaceutical policy not only prevail in Pakistan but also in many countries. In Canada for an example, the government faces the problem of balancing a dual role of encouraging the industry while at the same time containing the costs of pharmaceutical products [26]. But in developed countries these issues are debated and there is a widespread knowledge in most sectors of the society. However, in Pakistan academic and scholarly research on these issues is slight or non-existent and industrial achievements are considered a panacea for all ills.

Moreover, conflicts in pharmaceutical policy are more obvious in countries where the pharmaceutical industry contributes considerably to national R&D and investment [27]. In these countries government control may has some negative impact on the growth of pharmaceutical industry as has been seen in some European countries [27]. But this may not be the case in Pakistan where industry has a role in producing medicines but R&D is scarce. Though industry says it manufactures a wide range of research-based medicines, there are serious doubts about the research capacity as most of the raw material is imported and the industry is mostly producing finished products [28, 13] Developed countries such as Japan, Germany, Switzerland, and the UK have created enormous wealth from the pharmaceutical industry by rigorous innovation and at the same time strong emphasis have been placed on access and affordability. In the UK, drug companies have to invest in research and development proportionate to their revenues [29], but in Pakistan, there is little regulation or enforcement of monitoring how much the industry is spending on drug promotion versus research and development.

Another example of the weakness of the National Medicine Policy is the lack of appropriate human base and expertise in the field of health and pharmaceutical policy. For example, drug prices are a contentious issue and prices are considered high and unaffordable for the masses [25, 30]. However, an analysis of the composition of the pricing board of the Ministry of health reveals that instead of having a health economist or pharmacoeconomist on the board it has a cost accountant as a member of the pricing committee [31]. Perhaps it is difficult for the health bureaucracy and for a cost accountant to understand the complex issue of medicines and health-the trade offs and flow on effects of not managing medicines policy well.

Proposed Drug Regulatory Authority in Pakistan

Because of the inadequacies of existing Drug and Quality Control Organization now the government is planning for a drug regulatory authority [24]. Forming an independent Drug Regulatory Authority (DRA) was a long overdue step and it must be applauded, however serious concerns have been raised regarding the governance structure and financial autonomy of the authority [5]. It has been stated that the authority will be totally dependent on the service fee from pharmaceutical industry for its operation [5]. Other than service fee, there is a need to fund the authority by Ministry of Health so that DRA can function independently. Also, sole purpose of forming such an authority should not merely be to encourage exports; government should fulfill the responsibility to act for its citizens’ safety and well being especially in an area like medicines quality, safety and efficacy where citizens cannot have expertise to make technical decisions for themselves.

Lessons Learnt – A Way Forward!

Other than just producing more medicines, the government needs some decisive actions to promote public health and wellness through education and information.

Favorable government policies for the pharmaceutical industry may not solve the problems of irrational drug usage and access to medicines in the country. Technological innovations and research & development within the pharmaceutical industry are also not a guarantee for universal access to medicines. A vigilant approach to establish a balance between economic interests and public health objectives is required. The government can commission research and stimulate a debate on how the innovative capacity of the industry can be increased without compromising on public health. The government should not regard the pharmaceutical industry as the only stakeholder in its consultations, but should also discuss the issue within a broader framework with public interest organizations. The need is now unavoidable to create awareness among lawmakers, healthcare professionals economic managers and among concerned citizens. Without these steps the objectives of equity, access, safety and affordability seem hard to be fulfilled.

References:

1. Draft Drug Regulatory Authority Act, 2006. http://www.dcomoh.gov.pk/downloads/DRA-ACT-2006.doc?PHPSESSID=3bbf04631c13d91da5238e09fd6c8fb1
2. Prices of drugs in Pakistan are freezed at the level of prices during December 2001.http://www.pharmabiz.com/article/detnews.asp?articleid=28561§ionid=42
3. Drug Control Authority, Ministry of Health, Government of Pakistan. Available at: http://www.dcomoh.gov.pk/ (Accessed on 6/11/05).
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Footnote: Note: In this article the terms “Drugs” or Medicines” and “ National Medicine Policy” or “National Drug Policy” have been used interchangeably and have the same meaning.