Barriers to access innovative, life-saving medicines

as factors affecting universal health care
2019

Fernando Lamata Cotanda
Member of the Fair Access to Medicine Association

Only that which we do not propose is impossible. In making proposals we can change, for instance, the current model of medicine patents and monopolies to achieve access to essential medicines for all.

On 25 September 2015, leaders from different countries adopted the SDGs (mentioned already in this chapter), among them Target 3.8, which encompasses Universal Health Coverage and “access to safe, effective, quality and affordable essential medicines and vaccines for all”.

The starting point is the two billion people or more around the world with no access to the medicines they need and the 10 million people dying every year because of it. Every day across the globe the right to health and health care is infringed. We still have a long way to go.

The most recent change, in comparison to past eras, is that this is not just a problem pertaining to lower-income countries. Those of us living in wealthier countries thought it didn’t affect us — “out of sight, out of mind” — but now we are aware that it is a problem affecting the whole planet, including medium- and high-income countries. This is a situation, as we will see, that also offers an opportunity.  

Indeed, over the past 25 years, since patented medicines became widespread with the agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS), the prices of medicines and the pharmaceutical industry’s revenues have been growing unjustly.  

The paradigm of the new situation was defined by “Sofosbuvir”, a new anti-viral therapy used to treat Hepatitis C directly. A new medicine that was effective but priced so high that it was inaccessible not only for low-income countries, but also European countries and thousands of patients in the United States. A medicine for which, according to a study by Swathi Iyengar and other organisations from the World Health Organisation (WHO), companies demanded a treatment price that represented an average six-month salary, or even a year’s and up to a five-year salary, depending on the European country studied.

Medicine for which we have paid 20,000 euros per treatment in Spain, in the knowledge that its cost is below 300 euros per treatment and knowing the R&D cost had been made back by the company in its first year’s turnover!

The price hike of new medicines has impacted health care systems, affecting their stability and millions of patients in the process. Instead of fighting against large multi-nationals to lower prices, some governments have reduced the percentage of the population with a right to public health care, while others have increased co-payments for certain medicines.  

In Spain’s case, according to the 2018 Health Barometer, 1.4 million people could not buy medicine prescribed by their doctor in public health care. In the case of Hepatitis C, it demonstrated how high prices forced a delayed approval of public financing in different countries, or that rationing (only for specific levels of illness) was established. Furthermore, high prices are causing shortages in different medicines and we are seeing companies demanding unjustified price increases, in search of the same margins as “Sofosbuvir”. These exorbitant prices also make governments allocate growing amounts to the pharmaceutical industry, at the expense of other needs such as prevention programmes, staffing resources, improved infrastructures, and so on. This indirect effect translates into a lower response capacity for services and lower quality, increased waiting lists and poorer evaluations of public health care. Equally, part of companies’ excess income goes to marketing, influencing medical staff to increase prescriptions and thereby causing the unsuitable use of medicines and significant adverse effects.                 

In the present Report, a question was already raised about whether the real cause of the lack of access to medicines “is due to the ineffective governance of global health and/or the voracious greed of the pharmaceutical industry” (p. 40). Both of those things, in my view. Let’s take a look: although not the only cause, lack of access is mainly brought about by high medicine prices, and these high prices are set by companies and accepted by governments because companies have a monopoly. This monopoly gives rise to patented medicines and other exclusive instruments approved by parliaments. In other words, the monopoly is provided by society. We provide it. But why? The argument is that this twenty-year monopoly will allow them to set surcharges and cover their outlay on research and they will, therefore, develop new treatments to the benefit of all patients. The patent will work as a kind of tax on the price of medications, charged directly by the pharmaceutical industries supposedly to fund research.

The problem has come about through companies’ ever-increasing greed and governments’ ever-increasing lack of governance, contributing to this industry-set surcharge, this indirect tax — much higher than needed to cover research costs. In Spain we overpay the pharmaceutical industry (in addition to the cost of manufacturing) in excess of 9 billion euros per year, and they only spend 1 billion euros in research. The rest is pure profit. The same thing happens in Europe and the rest of the world.  

We can understand companies’ greed and profit-making approach as a driving force. Understanding governments’ ineffectiveness to avoid these abuses is not quite so easy to understand. As the United Nations Secretary-General admitted when, in 2015, he assembled a High-Level Panel on Access to Medicines: “the failure to reduce the prices of patented medicines has resulted in millions of people being denied access to treatments that would save their life…”.

If the root cause of high prices is monopolies and if national governments have failed when it comes to controlling these prices, then there must be a consideration to remove these monopolies. The solution to this serious problem lies in banning medical patents and any form of health-care monopoly, yet to do so we need a global approach. One country alone is not enough, for if it tries to apply mandatory licences (which allow generic products to be manufactured or imported) or tries to fix prices closer to the manufacturing cost, companies and their associations have enough power to lean on the government, delay the launch of a medicine, hold sway over scientific societies and opinion leaders, and force through the acceptance of their conditions. Therefore, a global political response is required.  

The aforementioned medicusmundi and Médicos del Mundo Report, in mentioning the Astana Conference, asserts:

“Perhaps the most critical aspect, at least from the point of view of civil society, is the absence of an analysis and strategy to deal with the political and economic causes that have meant large barriers for equal access to health services. In Alma Ata, there was the assumption that a new international economic order was necessary to ensure people’s health…” (p. 58).     

Undoubtedly, this analysis and strategy is needed, and we must also drive forward a new international economic order. Today, we inhabit the economic order produced by the revolution of the rich, which began 25 years ago, in which 1% controlled over 50% of resources. A new global financial capitalism. In the face of this capitalism we require a multi-national, global and political response.

The problem with the lack of access to medicines is one among many other major problems — hunger, lack of water, lack of access to education, wars, etc. — which are all interconnected. Yet in the case of medicines, as highlighted above, it offers us an opportunity. It affects us all, North and South, and we can back a common social response. It is not enough for low-income countries to achieve voluntary licences, since this is part of the mechanism that sustains the system of patents. It is not enough for the net total of official support to be increased for development intended for medical research and basic health care sectors, as stressed in indicator 3.b.2. from the Sustainable Development Goals. We must radically change the system, design a strategy that leads, in 2030, to an international conference prohibiting medical patents and promoting a global fund for medical research. In this global fund the agenda of research will be defined by health issues and not commercial interests, research will be open, and research findings will lead to manufacturing medicines at cost price.  

In addition to a strategy, political leadership is needed — “new Mandelas” who lead this new struggle just as he led the fight against the pharmaceutical industry to tackle the AIDS epidemic. And we need the mobilisation of civil society. I’m convinced that, in a similar fashion to what occurred then, with a strategy, political leadership and social mobilisation this objective can be met.  

A small step in this direction will be taken in Spain with the Popular Legislative Initiative “medicines at a fair price”, launched by 16 social organisations in an attempt to change the medicine law and spark a national debate on this important issue. This is a local action, but one that joins many others, in Spain, Europe, and around the world. It can contribute to achieving this “new international economic order that ensures health for all”, where nobody goes without medicine they really need.