What the "Patent Apocalypse" Really Mean for Big Pharma & Global Health
This piece first appeared on the AshokaTech blog: http://tech.ashoka.org/node/4504The True Apocalypse in the Global Pharma EcosystemBy now you may have seen or heard of 2012, the movie that is. I only saw it recently, and only by the grace of KLM’s onboard entertainment system. It is standard fare from the apocalypse genre. The Earth has a cyclical destiny, which involves at crucial points in this cycle a confrontation with some life-wiping monstrosity. In the movie 2012, the choice of monstrosity is also pretty standard fare – a disease in the Earth’s crust, mangling the Earth’s magnetic field, displacing the continents, and necessitating the building of a new Noah-type ark - or rather a number of them. I was not so much worried about the plausibility of this disaster movie as I was about its fatalist non-consequentialism. There isn’t much we can do about unpredictable Earth-chewing bugs now, is there? To all intents and purposes, whatever moral was in the tale of 2012 cant matter much to the lives of you and me. I have had another kind of apocalypse in mind these past few weeks. It would make for a most underwhelming disaster movie though, and I have no intent of dramatizing the issue. But as quasi-seismic events in the health of the species go – and the fate of the species and the planet are much conjoined nowadays, are they not? – this one is worth at least a cursory thought. In 2012, the planet faces what the sensationalist press has dubbed a “Patent Cliff”, though a “patent trough” is much closer to the mark of veracity. Because the issue, when one takes a deep enough look at it, is more one of major global drug companies losing their edge in the game rather than just their most valuable drug patents, and it is largely up to them how long they languish in this abyss they have in a certain sense dug for themselves. There is no denying the fact that the massive expirations of patent protection that shall hit major drug companies will create considerable threats to their profitability. The world’s biggest blockbuster drug, Pfizer’s lipitor, whose annual sales outstrip the GDP of most West African nations, for instance, will be faced with stiff generic competition. Other blockbusters like Sanofi-Aventis’ plavix, Merck’s cozaar, Pfizer’s Viagra, and Bristol Myers Squibb’s Abilify are in the line of fire too. Forest Laboratories, Pfizer and Astrazeneca are, according to the research outfit Zack, said to be the big pharma players most threatened by the coming upheaval. You would have thought Health Activists would be rejoicing. After all, it is frequently argued that pharmaceutical patents are one of the key blocks to increasing access to essential medicines in the developing world, and that increased generic competition should improve upon such access in the poorest parts of the world. The truth is that health activists have moved on. While the press still enjoys portraying the issue of low access to essential medicines in places like Africa as consisting chiefly of titanic struggles between reformers and greedy big pharma, the situation has evolved, quietly but substantially, into one of relative complexity, wherein collaboration, cooperation, and cooption amongst foundations, activists, big pharma, intergovernmental agencies and NGOs are the order of the day. It is no longer the consensus that ditching patents automatically improves access to essential medicines. Indeed most of the diseases that afflict the poorest parts of the world can be effectively managed by medicines that have been around for almost 3 decades (patent protection in most jurisdictions last for 2 decades, and because of extensive clinical trials may have an effective lifetime of 15 years or less, though of course it is also true that pharmaceutical companies try hard to extend the lifetime of such patents through shrewd tactics). In Ghana, for instance, despite the lack of detailed empirical data, my own direct observations and credible anecdotal evidence suggest that systemic waste and a chronically outmoded financing regime are the key barriers to access. A chaotic public distribution system means that oftentimes even free in-patent medicines do not reach poor patients. It is hard to conceive how any generic medicine can compete with a zero-priced patented rival. Which raises another issue. It has also come to light, that the erstwhile fixation on market pricing, especially of branded medicines, ignored the emergence of production capacity even in the poorest countries, such as Ghana, Togo and Nigeria. These upstart producers often consider their business to be at greater risk from other generic producers in places like China, India, Asia Minor and Eastern Europe. More curiously, the same local producer of a cleverly selected portfolio of generics targeted at a niche in the local market would also usually be the local representative of a major multinational brand in other niches. Indeed, most generic producers in the Deep South built the capital needed to enter the industry by initially acting as representatives of overseas brands. And already, the generic industry has begun losing its erstwhile saintly aura, as activists realize that these guys are in the business to grow and make profit too, and at a certain level of expansion acquire most of the characteristics of Big Pharma (as the recent allegation by European antitrust authorities of illegal collusion between Teva, a major Israeli generics producer, and Sanofi-Aventis appear to indicate). At any rate big pharma's entry into the generics space blurs the casual distinction between the two categories of the industry. Simply put, it has become less cut and dried what factors most effectively promotes access to quality medicines in under-resourced regions of the world. As new models of cooperation between disparate actors in the pharmaceutical ecosystem in the South emerge, the health of the pharmaceutical industry in its entirety – branded as well as generic – is increasingly being seen as important if the endgame is really about improved access to quality medicines in the Global South, rather than anti-capitalism generally. Such models as patent pooling, which allows different organizations to group specific patents in order to deliver a particular product, usually in accordance with a set standard, are gradually penetrating the mindset of the pharmaceutical industry, enabling the prospects of new value chains. We have also seen foundations such as the Medicines for Malaria Venture (MMV) enter the pharmaceutical innovation space, bringing the tried and tested advantages of social entrepreneurship into the this difficult arena. Some big pharma players now see the strategic importance of re-conceptualising the nexus between commercial profitability, research and development, and goodwill (see this paper for some common criticisms). They now see an emerging pharmaceutical industry less anchored on blockbuster molecules and more reliant on a company’s relevance to health systems holistically defined. The issue is what they are doing about what they are seeing. The aforementioned point may sound somewhat novel or arcane, but it is actually pretty straightforward. There is widespread agreement amongst scientists that the geographical patterns of disease stand to change in a more interconnected, populated, socially experimental, world. What is now considered a disease of the South may soon become commonplace in the North, and vice versa. Furthermore, as attention shifts from palliative care and disease management to general wellness, cultural notions of medicine become much more relevant and the very concept of pharmaceutical innovation, and R&D in particular, must adapt to keep pace. That is why I hinted earlier on in the discussion that the obsession with so-called “Patent Cliffs” risk oversimplifying the true, variegated, picture that is emerging. The industry is entering a stage where traditional models of valuation for intellectual property, particularly patents, are showing their frayed bottoms. Those within the industry who cling to the old heraldry of innovation are increasingly sounding like those moribund health activists who latch on to patent-bashing as a convenient means of hiding their inability to confront a rapidly changing ecosystem. There is thus a genuine onset of a “patent trough” – a period of decreasing contribution to industry vitality of the old conceptions of intellectual property, especially the over-reliance on blockbuster patents. A world of tighter margins beckons - a world of patient-centredness and value dispersion that shall not be kept at bay by the artificial consolidation of mergers and acquisitions sweeping big pharma. The possibility that both drug producers and health activists may have failed to adequately prepare for the realities of this new world is where we must look for any hint of true apocalypse in the global healthcare space, else whatever Noah’s arks we build shall sink.**Bright B. Simons is affiliated with the African think-tank, IMANI (www.imanighana.org), and is the inventor of the mPedigree approach to drug quality assurance (www.mPedigree.Net)**
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