Lead Author: Olivier Okakessema Nyamana
Organization: Groupe de travail sur les droits humains et le VIH en RD Congo; Horizon Justice et santé ASBL (ex Avocats au Ruban Rouge ASBL)
Country: Democratic Republic of the Congo
The author describes three local situations that illustrate the issue of innovation and access to medicines in the Democratic Republic of the Congo (DR Congo).
First, he addresses the contrast of a pharmaceutical firm in a country where industrialization is hardly a hallmark, one that has had the opportunity to produce antiretroviral (ARV) drugs and contribute to satisfying local, even regional demand, but whose momentum was halted by international mechanisms for certifying a medication already in use elsewhere, for which the firm had only obtained a license; and also by other requirements, particularly to compete in international invitations to tender against major companies that operate on a different level entirely. This obstruction was perceived locally as a protectionism for the interests of companies from countries that donate and lend ARV drugs, and the author calls for adapting the criteria for marketing medications in the future using a proactive approach of empowerment for developing countries.
Second, he describes the usefulness of traditional medicine, which remains the last resort for medications for the Congolese population in times of crisis and conflict when the mainstream or modern medical system has become dysfunctional, by way of defending the efficacy of this type of widely used treatment, which, after all, forms the basis of modern pharmacopeia, but has been slow to achieve legitimacy.
Finally, he denounces the abuses of a few promoters of dietary supplements and other scam artists, who victimize the consumers of their deceptive compounds, delaying them from arranging access to care that is relevant to their case. Subsequently, he underlines the need for addressing these setbacks.
Promoting innovation and access to medicines in DR Congo
We wish to present our contribution without pretensions; however, in order to achieve even this modest task, we feel it indispensable to be concrete in the stigmatization of these issues, specifically to consult the available literature, as well as interviews with several key informants, to support or disprove our perception of the issue of innovation in the medical field and of access to pharmaceutical products, so that we may submit to the Committee the most objective information possible that could have even the slightest relevance. We have also consulted a number of available documents to form a more educated opinion, but at this stage we have not been able to obtain all the data we sought, particularly in terms of statistics, given the waiting times for responses to our requests for them. Nevertheless, we have also gathered information available in articles and reports on the internet.
Availability of medicines, Pharmakina Bukavu case: a missed rare opportunity to promote local production of ARV drugs to satisfy local demand
With an estimated population of 70 million inhabitants, the Democratic Republic of the Congo (DRC) constitutes a potentially interesting market for pharmaceutical firms, despite the weak purchasing power of the majority of the population. Since 2002, the country has employed a National Essential Medicine Supply Program (NEMSP), which currently contributes to implementing the national pharmaceutical policy adopted in 2008. In addition, the DRC has twenty or so pharmaceutical production laboratories, most notably those with Indian origins, which hold the upper hand in the sector, but these only cover 15 to 20 percent of the national consumption; the rest is imported. In its introduction, the pharmaceutical policy manual criticizes the insufficiency of local medicine production. However, if industry representatives are to be believed, the issue does not lie at the level some patent law or other that would hinder their room for maneuver in producing generic medications to satisfy demand, the fabric of the pharmaceutical industry being too underdeveloped to autonomously and optimally profit from the flexibilities provided for in the TRIPS Agreement or even in the Doha Agreement, unless there is also a lack of interest in doing so. As an exception, the legislation on industrial property of 7 January 1982 already provided that drug patents be accorded for fifteen years, as opposed to twenty in other cases, before entering the public domain, as an ethical consideration seeking to limit profit in a such a socially vital sector. Above all else, the problem is availability and accessibility, both geographic and economic, of these medications, but it is also quality control. In particular, it should be considered that the DRC is a vast tropical country with a population dispersed over an immense territory, with serious accessibility and communication problems and in the grip of widespread poverty. Multiple governmental challenges must also be addressed, not least of which are production control, supply and distribution of medications.
Given this situation, we feel it pertinent to describe the emblematic and contradictory case of Pharmakina Bukavu. This pharmaceutical company, which is Congolese by law but was first owned by German shareholders before passing into Swiss hands, was founded in 1942 and is based in the eastern part of the country. Its core business is production of quinquina, the active ingredient in which is used to make quinine. In 2005, it inaugurated with great pomp an antiretroviral production site dubbed “Afrivir” after a license allegedly obtained gratis from an Asian industrial philanthropist whom we were unable to identify. But unfortunately, it was not long before disenchantment set in, because commercial success was not to be; the orders expected for this populated country, where the estimated rate of HIV-positivity reaches 4 percent, never came.
Inquiries into the source of the growing problem revealed that the partners who supplied the country with ARV drugs required a pre-qualification according to WHO criteria, as well as submission of a response to an international invitation to tender. The firm’s management quickly realized what prohibitive financial conditions and tedious processes this would require, and let go of their illusions. For local right to health activists, this episode revealed the limited sovereignty of a feeble State faced with inescapable external partners who fill in the gaps in its governmental powers. It is no coincidence that certain countries known to be more organized, such as Rwanda, have still been able to procure ARV drugs for their populations. In fact, the Congolese government has been deplored for its lack of political will to assist and support a national pharmaceutical flagship in the aforementioned pre-qualification process.
Today, Pharmakina has closed the book on ARV drug production; nevertheless, we believe that there is a lesson to be learned from it, for it is unacceptable that at a time when the waiting list for ARV drugs is long, a wait that is sometimes fatal, the stakeholders in this matter failed to take a proactive approach to supporting local production. True, an invitation to tender means competition, but we share the point of view that not all basic needs should be subject to the law of the market, especially when lives are at stake. Indeed, the right to life is the first of all human rights; it is sacred and has no price, and consequently the commodities essential to maintaining it cannot be reduced to a purely mercenary value.
Thus, we recommend that within WHO and in other relevant instances, the rules for pre-qualification be relaxed and integrate accommodations for supporting promotion of the local industry in order to promote the well-being of the population in question. We admit that in a time of economic crises, financial considerations cannot be put aside; furthermore, we recognize that we do not possess all the objective information needed for an educated appraisal of the situation described above. However, we firmly believe that the step we are proposing is worthwhile, because it is a question of policy coherence, so far as there is agreement that the interest of the beneficiaries should be the ultimate criterion that supplants all others. The policy should always be to serve the people, and not fall into sterile bureaucracy.
Life is the first of all rights within the realm of civil and social rights; that is, the first generation human rights, as they are known in various instruments of human rights. Article 16 of the Congolese constitution, in the manner of other texts such as the Universal Declaration of Human Rights or other regional charters with similar dispositions, declares that “the human person is sacred. The State is obliged to respect it and to protect it. All people have the right to life, to bodily integrity, and the free development of human personality in respect of the law, of public order, of the rights of others and of morality…” Life has no price, life is sacred, and therefore the commodities essential to maintaining it cannot be reduced to a purely mercenary value.
Framework for traditional medicine: demonstration by contradiction of its necessity with regard to recent crises in DR Congo
As one author points out, traditional medicine has regained attention and interest in urban African settings over recent decades. It is well known that Africans resort en masse [to this] form of medicine. Based on this reality, WHO’s strategy since 2002 has ordered the governments of member states “to integrate relevant aspects of traditional medicine within national health care systems by framing national traditional medicine policies and implementing programmes; and to promote rational use of traditional medicine.” In response to this recommendation, other national texts, such as the national pharmaceutical policy, offer the same idea in the form of several proposals for crisis applications, but even so, the implementation process seems particularly laborious. Statistics would shed even more light on the need to validate traditional medicine; for example, according to the Ministry of Health, in 1998 in the DRC, there were approximately 4.4 doctors for every 100,000 inhabitants, one of the lowest numbers in the world, which coincides with the country’s poverty. Also in 1998, there were about 58 nurses for every 100,000 inhabitants in the DRC. In contrast, in the province of South Kivu for example, according to one author, in the same year there were 200 doctors, or one doctor for every 13,250 inhabitants; and 648 traditional medicine practitioners, or one traditional medicine practitioner for every 4,100 inhabitants.
This wide availability of traditional medicine practitioners merits being capitalized upon. The recent experience of the DRC, a country that barely emerged from many crises and conflicts that disorganized and paralyzed its modern, Western-model health system, was a blunt reminder of the validity, the urgency even, of such an action. On this subject, the researcher Balagizi Karhagomba writes, “The war situations Kivu has endured have enabled local communities to take an approach of action-research based on sharing knowledge of medicinal plants, of reinforcing local capacity to promote local indigenous knowledge in order to satisfy medical supply needs. And currently, a harmony exists in the collaboration between traditional and modern medicine. Therefore, it makes sense for health care providers to document and promote local knowledge via participative experimentation aiming to promote traditional pharmacopeia and gear it toward the market.” But conflict is not the only reason for resorting to this form of medicine. More platonically, economic motives often come into play in a situation of collapse. Of all the actions recommended by different sources in the field in favor of traditional medicine practitioners, we believe there is good reason to give priority to the following:
- Creating of a codex of traditional medicine
- Forming an incentive that would benefit traditional medicine practitioners who agree to record and register their methods
- Training and endowment of material resources to enable those who wish to present their products in more conventional galenic formulations.
- Educating the population on phytotherapy and training service providers in phytotherapy by attaching them to health care zones, the community-based unit of the primary health care system in the DRC, which is destined above all for primary health care in the spirit of the Alma Ata Declaration.
When dealing with traditional medicine practitioners, it is common to hear them justify their refusal to register with fear of seeing their methods “stolen” by someone who would get rich off of their work, or more simply with the fear of being held back. Thus, it is important to find reassuring response to these concerns. Furthermore, industrial packaging of traditional pharmacopeia could prove to be profitable, as demonstrated particularly by the local success of the products Manadiar and Meyamicine from the pharmacist TONDELE, Manalaria from the pharmacist MBAMU, and the Herbopharma products from another herbalist.
In 2013, a census was taken of traditional medicine practitioners in the city of Kinshasa, which identified close to 2,500 of them, along with their work sites. This list is certainly not exhaustive, and spiritualists of all kinds must also be counted. But this at least constitutes a first step in the right direction.
The population’s confidence in this medicine, which is perceived as pushing past the limits of modern medicine, is accorded largely in terms of recovery results. It has even been shown that in urban areas, it can be almost as expensive, if not more, than modern medicine, proof that it has attained increasing credibility in the public opinion. There is also holistic medicine, in which providers combine roles that in modern medicine are divided between the many specializations of the medical profession. Thus, it is important to organize traditional medicine and not treat it with contempt, because in times of crisis it is traditional medicine that will prevail, since it is closer to nature.
Abuse of public trust in medications: The issue of false pharmaceutical advertising, dietary supplements, fraud and charlatanism and their negative impact on public health
They can be registered as dietary supplements at the Ministry of Health, but in the field, they develop via parallel circuits for distributing products that are presented as genuine, even quasi miraculous remedies, capable, for example of sparing a patient from surgical operation. It is often acknowledged that those in need of health care start with modern establishments before resorting to traditional medicine practitioners. But in the case of these exotic medicines, more and more people are using them as a first resort, and sadly, they most often end up in conventional hospitals after having bled out financially without getting the cure they counted on. Unfortunately for this very lucrative business, they sometimes have the support on the highest State level at their disposal, as demonstrated by the defiance of a Chinese remedy business, which the Minister of Health KABANGE NUMBI visited in person in 2013, only to be met with unexpected and stunning resistance. Their marketing practices are admittedly very attractive, with unprecedented, quasi aggressive methods that border on solicitation. Take for example the offers of so-called electromagnetic scanners, capable of providing comprehensive information on the body’s condition for a modest sum, ten times less than the conventional scanners at university clinics, whose three-hundred-dollar price tag is prohibitive for the little people, leaving aside the long waiting list. Citizens are not left out, because certain impostors would offer to perform all medical investigations solely on the basis of saliva—a nod, no doubt to those who have fears of needles and other punctures.
Similarly, the Congolese media landscape was at one time saturated with false advertisements for gurus who claimed to be able to cure practically anything, disregarding the legislation on this matter, specifically ordinance no. 70 / 158 of 30 April 1970, which prohibits all advertisements or publicity related to healing arts in the DRC, and which in the meantime seems to have fallen into oblivion.
These apothecaries of all kinds, whom we are denouncing here, have had ample time to get rich, especially in the wake of the HIV/AIDS pandemic, by profiting from loopholes in the system, and have often built up goldmines for themselves by shamelessly exploiting the distress of others. Without a doubt, the passivity and lethargy of the public authorities has formed the bed for grave violations of human rights, for here it is difficult to put a number on the casualties.
There is reason, therefore, for the public authorities and their partners to invest in dispelling confusion in the minds of an often illiterate and credulous population. Furthermore, it should also be clearly stated that dietary supplements are not medications, and their circuits of distribution must be supervised. The population is in fact often inundated with inappropriate offers, and left to themselves, they no longer know what treatment to seek!
There is a glimmer of hope that stamping pharmaceutical products and the process of making holograms are on track to help authenticate medications for final consumers, giving them access to quality products by reinforcing the control and identification system.
It is generally acknowledged that economic and social rights are still in the process of being achieved, but because the right to heath is directly linked to the first of all rights, the right to human life, it is essential that all decision makers consider that the secondary must follow the principal, and must therefore give it particular attention, for a healthy body and a health mind are the fundamental prerequisites of all sustained progress.
Olivier OKAKESSEMA NYAMANA
Kinshasa / DR Congo
Tel: +24 381 452 6922
Bibliography and References
Demographic and Health Surveys (DHS-DRC) 2013-2014
Mr. Clément WUTEJI, Head of Quality and Insurance division, Pharmacy management, medications and medicinal plants at the Ministry of Health
Director in charge of supplies, medications and equipment at the Ministry of Health
Director in charge of traditional medicine at the Ministry of Health