Name of Lead Author: Lal Manavado
Organization: Norwegian Directorate of Health
Country: Norway
Abstract
Human rights are meaningful to people, only if they are observed in the society in which they live. Extent to which they are observed in a society, reflects the degree of social harmony there.
Possibility of our living, depends on the possibility of our satisfying four fundamental needs, viz., education, nutrition, health and security in its broadest sense. Possibility of our existence as a species, depends on the possibility of our procreation.
The possibility of our leading a civilised life depends on the possibility of our adequately satisfying certain set of non-material needs like creative and aesthetic enjoyment, entertainment, sports, etc.
Social harmonyis essential to enable the members of a society to adequately meet those six fundamental needs. Hence, observance of human rights is in everybody’s interest. Its neglect would hinder some from adequately satisfying those needs including health.
As a result, burden of disease of that society would increase, which in turn, would adversely affect its division of labour, reducing the possibility some of its other members may have of satisfying their own needs. This would result in a self-expanding evil circle, where human rights loose theirmeaning to the people.
Enhancing their access to medicines and diagnostic material may help people to satisfy one of their neglected health needs, and may thereby restore theirbelief in human rights to some extent.
Submission
Towards an Enhanced Global Access to Medicines and Diagnostic Material
This submission postulates that while good health in a population promotes the observation of human rights, its ill health exerts the opposite effect by adversely affecting general law enforcement, which is essential for human rights to become an experienceable notion.
Other things being equal, ill health has an adverse impact on most human activities including the development of personal and national resources. Deficiencies in law enforcement and access to the requisite human and material resources are not felicitous either to innovation, or to the justifiable rights of an inventor or a trader.
Therefore, it would be in everyone’s interest to ascertain how one may accommodate the requirements of trade and patent laws on one hand, and meeting somemedical needs of ill health on the other for our mutual benefit. This submission is an enquiry into a possible means of achieving that objective.
Introduction
Our point of departure is that man must adequately satisfy six fundamental needs, viz., education, nutrition, health, security in its broadest sense, procreation and a set of non-material needs like aesthetic satisfaction, entertainment, etc., in order to continue to exist as a sentient and civilised being.
There is no justifiable way to determine which of the first four needs could be given logical priority, because the failure to satisfy one would inevitably lead to one’s incapacity to satisfy any of the others. Our knowledge of what those needs are, and how we may successfully satisfy them are not givens, and they have to be acquired by education.
Other things being equal, the possibility of satisfying those needs depends on the possibility one has in undertaking some suitable action to do so. The possibility of undertaking such an action depends on having the freedom to do so without hindrance from the other people. When a society embodies this freedom, a social harmony obtains there.
Thus, achieving social harmony is in everybody’s interest. Through a long social evolution, man has developed a system of do’s and don’ts to achieve this objective. Typically, it manifests itself as a system of ethics anchored in a belief system. Now it has grown into the current ethico-legal system which displays certain nominal regional variation.
Now, we need to distinguish between rights and laws. As enforcement of the latter is intended to guarantee the former, we can envision trade laws as a means of guaranteeing innovators’ and traders’ rights, which in turn, are only a sub-set of human rights.
Let us continue with health as our example. Other things being equal, people would be motivated to observe human rights, because it is conducive to their satisfaction of health needs. But should the reverse obtain, the resultant social disharmony will hinder them from achieving that goal. This seems to lead us into a Catch-22 situation.
When historical, political and economic reasons have deprived huge populations the possibility of satisfying their health needs for a long time, it is unreasonable to expect them to observe human rights and strive towards social harmony, for in everyone’s mind, one’s own health has a priority over other people’s rights or well-being.
There is a general agreement on the importance of good health as a major contributor to what enables anyone acquiring the abilities and skills necessary to satisfy one’s fundamental needs. Obviously, their adequate satisfaction is necessary, therefore desirable to all, hence, good health has a universal value.
Data from WHO clearly indicate that the global distribution of good health is very uneven owing to the comparatively high burden of disease borne by the less developed countries, and some of its component diseases like AIDS, Malaria, Tuberculosis, etc., are much less prevalent in affluent countries.
Furthermore, the current economic doctrine has had an adverse impact on people’s eating habits throughout the world. As a result, the so-called NCD’s have become a growing component of the global burden of disease. This seems to represent an exacerbating addition to the already considerable burden of disease observable in less affluent countries.
Other things being equal, this entails that the inhabitants of less developed countries are at a considerable disadvantage with respect to adequately meeting their fundamental needs, or acquiring those abilities and skills necessary to successfully satisfy them.
Meanwhile, spread of information about human rights and popular political doctrines have raised people’s level of expectations to a comparatively high level. In this environment, their reduced possibility of satisfying their fundamental needs, would increasingly undermine their confidence in rule of law essential for social harmony.
As a consequence, some may react with indifference to rules that might manifest itself in some form of escapism or social lethargy. Response of the others may range frompolitical demagogy to violent anti-social action. Where these predominate, the question of human rights and material progress becomes academic.
Thus, good health seems to be an important factor that imparts a tangible value not only to human rights per se, but also something needed to enhance the social harmony that springs from each member of a social group having the possibility of leading a life of contentment in dignity. It is their role in sustaining social harmony that justifies attributing a value to respect for law and human rights.
Meanwhile, lack of an adequate access to health care promotes the evil cycle of ever-growing social deprivation and the associated danger of violent social upheaval. Neither of these can be a part of the ambience where inventions are made and turned into innovations, or human rights are adequately respected.
Researchers, creators and purveyors of medicines and diagnostic materials depend on international sales for their livelihood, As the number of those who have no access to needed health care increases, the possibility of someone circumventing the justifiable claims of the inventors and innovators and the trade laws will continue to increase.
Production and sale of ‘pirate medicines’ is already a growing problem. However, in spite of their questionable quality, their sales appear to be lucrative enough to encourage this malpractice, because desperate people will seek whatever means at their disposal to alleviate their sufferings.
To sum up then, inadequate access to medicines and diagnostic material is a hindrance to good health, which in turn adversely affects the possibility of many members of a society satisfying their fundamental needs, which would disrupt its harmony. Its diminution would make human rights, patent and trade laws an irrelevance to the people.
The Problem
The path from undertaking an invention to its practical application is not only expensive, but also requires highly specialised human resources and materials. Most countries with a high burden of disease have neither the financial nor the other resources required to develop and produce the medicines and diagnostic material they need.
Other things being equal, If our respect for human rights is claimed to be global in scope, it implies that we must undertake steps not only to ensure our own respect for those rights an laws, but also initiate actions to enable the deprived billions to experience the desirability of respecting human rights and the rule of law.
Attaining this objective entails helping the deprived to achieve social harmony in their midst. The possibility of doing this, depends on their ability to adequately satisfy their fundamental needs. Their health needs are one of them, which remains inadequately satisfied.
Thus, our problem now is how to enable the deprived to achieve an adequate level of health in a way that takes into account the justifiable claims of those create, develop and sell medicines and diagnostic material. This is not a question of charity or historical guilt, for it benefits all.
The reason is quite simple. Nation states have become increasingly dependent on each other to varying degrees. Violence brought about by desperation can spill across frontiers triggering greater misery. Moreover, it reduces trade including that in medicines and diagnostic material.
A more serious problem is the unpredictability of pathogen emergence. Nobody can rule out the transformation of currently mild pathogens into virulent ones, or hitherto endemic one becoming a pandemic agent as Ebola and Zika viruses have demonstrated. These events have taken place in areas of relatively high burden of disease and less affluence.
Neither violence nor pathogens are respecters of national frontiers. Transport of people and goods on which all creators, developers and sellers of many kinds of product including medicines and diagnostics depend, could serve as a vector of disease, and may need to be restricted, which would result in financial loss.
The Criteria a Solution Must Meet
We will call them the criteria of universal adequacy, because they embody the principles on which a solution acceptable to all reasonable people could be based:
1. It will ensure an adequate reward to those who invent, develop and market medicines and diagnostic material.
2. It will make medicines and diagnostic material accessible/available to the maximum possible number of those who need them but are unable to afford them.
3. It will protect one’s justifiable right to intellectual property and patient’s right to product or service of adequate quality, and it will strive to uphold justifiable trade laws.
A Possible Means to the Desired End
Apart from the obvious, i.e., seeking the best means of increasing the global access to medicines and diagnostic material needed, it would be useful to prevent increasing the need for them. This latter requires an effective parallel undertaking to expand national endeavours in prevention.
To improve access to affordable medicines and diagnostic material one may resort to two distinct means, viz., internal and external structural and functional efficiency. We will begin with the internal or the national means.
Irrespective of the political colouration of a government, its implemented policies would have a significant effect on national health, and by implication people’s access to medicines, vaccines and diagnostic material. Funds available for their local production or procurement depend on the degree of congruence among relevant policies, and adequacy of their implementation.
A congruent set of policies can be envisionedas a hierarchical network of them, where those above can logically subsume some of those below them. At their top, stands the intent to enable all the citizens to adequately satisfy their fundamental needs including health.
Since it is unjustifiable to give priority to any one of the fundamental needs, policy on health should be given the same priority as the others. Next, policy makers should identify the policy areas where they overlap health. For instance, health consequences of dietary imbalance are well-known.
Moreover, the role environment plays in making agriculture possible on earth, and in buffering extremes of climate are well established. Likewise, appropriate education is vital to better national health. This analysis can be fruitfully continued to map the important policy areas where their congruence with health policy would enable us to achieve much even with limited resources. This requires high analytic and synthetic abilities.
An example of policy incongruence relative to health would be a trade policy that permits import/production/sale of inappropriate industrial food and drink known to promote dietary imbalance. This is a serious problem in affluent countries, and thanks to the dictates of ‘free trade agreements’, its ill effects are already visible in poor countries.
The next step is policy implementation. It requires a good deal of technical and administrative competence, whose global distribution appears to be somewhat thin. Now, we may justifiably demand a similar policy congruence and implementation competence from the regional and global institutions concerned with health.
At a minimum, we can begin by looking at the health implications of current GATT without succumbing to the temptation to achieve economic growth at the expense of national health. Other areas that require urgent scrutiny include pollution, disposal of dangerous waste, Law of the Sea, and environmental degradation.
Even after achieving policy congruence with respect to health and an adequate policy implementation, the first principle may seem to offer insurmountable difficulties, because many of those who need medicines and diagnostic material cannot pay what inventors, developers and purveyors of those items collectively consider to be sufficient.
I think it would be worthwhile to establish an impartial international technical panel whose brief would be to ascertain a fair price for most needed medicines and diagnostics. Their expertise should include Pharmacology, needs of surgical and clinical practice, epidemiology, laboratory diagnosis, finance, business practice, and the relevant law.
If international consensus on the decisions of such a panel on prices is obtainable, it would be comparatively easy to proceed. One wonders whether the UN might be induced to procure political support essential to establish such a panel, and whether it is possible to induce pharmaceutical industry to be guided by its decision.
True, introduction of a new medicine or a diagnostic method is a very expensive undertaking. However, there are many established medicines and diagnostic methods, whose present cost does not always seem to be justifiable. Moreover, their potential increased sales may warrant considerably lower prices.
As an adjunctive means, I strongly advocate a technically and legally unambiguous definition of ‘generic’ medicines and diagnostic material. As sale of such products may already have amply repaid those who made their sale possible, it would be justifiable to display here some bias towards the health of the needy.
Now, I would like to propose two somewhat novel combinations of a few well-established practices. Their novelty lies in that they strive to make gains made by all involved parties commensurable in the absolute sense. The first is cooperative pharmaceutical research, while the secondis concerned with establishment of pharmaceutical cooperatives to make, distribute and sell quality generic medicines and diagnostic material on a non-profit basis.
Research cooperatives may consist of hospitals, universities, medical research institutes, and any other accreditedbody appropriate for the purpose. It is preferablethat they are publicly funded. Source of their fundingis immaterial as long as all partners of a cooperative are willing to have the same share of the patent, and accept that takeovers are forbidden.
Pharmaceutical cooperatives may be national or multi-national, and in my view, they would be most effective if they are designed to providemedicines and diagnostic material for which its region has the greatest need. It could pool regional technical expertise and financial resources.
My next suggestion is concerned with dealing with the fact that forsome time to come, pharmaceutical cooperatives with the help of cooperative research will not be able to provide some medicines and diagnostic materials at a low cost, and it might not be easy to find the financial resources needed to establish them.
I propose the establishment of a UN Medical Supplies Development and Procurement Agency (UNMSDPA). A transparently run technical body, its purpose is to assist cooperative research and pharmaceutical cooperatives financially up to a point, and to negotiate the prices of most needed medicines and diagnostic material for purchase, buy them and distribute them at suitably subsidised prices.
I have not described UNMSDPA at length, but the rationale behind its establishment as well as that of research cooperatives and pharmaceutical cooperatives, is to show some regard for human rights in practise. For millions of sick who need medicine, it is already too late, but, there are millions more to whom we can show what regard for human rights may mean in real life.
Limitations and Obstacles
The followingis a non-exhaustive list of limitations the present proposal will have to surmount:
1. Shortage of people with the requisite analytic and synthetic skills with respect to holistic, hence fully congruent policy formulation.
2. Availability of persons skilled in implementing congruent policies.
3. Institutional barriers in place to safeguard institutional autonomy may limit inter-institutional coordination in practice.
4. Willingness among the relevant organisations to engage in cooperative research as described.
5. Willingness of national/regional producers to engage in cooperative pharmaceutical production as described, and if they are, their access to required funds.
6. Great diversity among multi-governmental and NGO’s concerned with health, whose fragmented effort leads to inefficient use of resources, and would limitthe resources available to the proposals made here.
As for the obstacles one needs to overcome, the following are among the most significant:
1. Tendency to place undue confidence in the so-called evidence-based approach, which practically excludes new ways simply because there cannot be any evidence of their adequacy.
2. Geometric proliferation of data that blinds the planners and decision-makers precisely in the same way as one does not see the forest for trees.
3. Difficulty in inducing the decision-makers and planners to adopt a holistic approach to problem solving.
4. The implicit motivator of modern economy, viz., the possibility of making profit ad libitum, which effectively excludes the human rights considerations from it.
5. Lack of willingness among international trade and economic organisations to revise their rules in a manner that promotes a more equitable economics.
6. Sequestration of an undue share of the world’s nett financial resources in comparatively few private hands.
7. Tendency among those working in global health to use reductive solutions on their favourite fields.
Moving Forward
Eliciting the global political willingness to undertake a collective humanitarian action to meet an obviously urgent need seems to be the only way of countering the limitations and obstacles this proposal would meet. A meeting of political leaders on the issue may be of some use here.
Extensive dissemination of plain information on the extent of actual suffering of millions owing to lack of medicines and diagnostic material may induce the public to demand helpful changes in governmental perception.
In conclusion, vaccination has been excluded because of the existing successful endeavours to promote it. However, some vaccine production may be incorporated into the proposed scheme. I think it is time to admit to ourselves, we fail not for the lack of resources, but for our unwillingness to use them as we ought.
Bibliography and References
On linkages among health, nutrition and environment, please see: