Pharmaceutical patents: Lives lost in the rule books

I was visiting a friend, a social worker come activist working with the poorest in Kampala. One meeting I had plagued me, a fragile and sullen lady who was tending to a modest stall. She is a victim of HIV/AIDS, her husband dead with two demanding children, and without the vital medicine she is facing her own death. She has too little like a lot of people but she best embodies a grim reality, too little means becoming consumed by other’s interests. This article explores these interests in the pharmaceuticals industry, their ‘corporate agenda’ and the failure of humanity on the streets and in the rule books. Pharmaceutical patents come under the terms of Intellectual Property Rights, the time that a company can hoard secrets and profits. Since 1995 this has been enshrined in a World Trade Organisation (WTO) brokered agreement, Trade Rights for Intellectual Property (TRIPs) with which some reforms makes the current rulebook for pharmaceutical production. There are plausible justifications to the patent system. The argument follows that they incentivise companies to invest in the lengthy research needed for production and cover the associated financial risks of unsuccessful production. The popularity of patents was furthered by subsequent reforms in the 2003 Doha Round to improve access for the poorest. The August 30 agreement - hailed by humanitarians as an example of market responsibility - saw a key article changed. Previously countries could produce generic forms of branded patents but they couldn’t export, harming the poorest countries whose infrastructure couldn’t provide for domestic needs. The reform permits countries to import generic drugs in a public health emergency. Kofi Annan described patents as, “the key to bringing forward new medicines urgently needed for the health of the world’s poorest people.” However, these arguments are misguided and narrow, showing the incapacity of decision makers to think beyond a market solution to a pressing global need. The patent system actually ignores the best aspects of the market system, competition, but retains it’s ugliest: relentless seeking of profits, inappropriate representation of big business interests and disregard for people, the poorest people. The system contradicts the fight against the most deadly and endemic diseases. These endemic health issues require effective and affordable drugs. The patent system is officially 20 years but pharmaceutical tricks frequently extend this period in what’s termed ‘TRIPs Plus’, a manipulation of legal loopholes. The costs of these drugs in this patent period are averagely four times more expensive than non-branded drugs and frequently higher. In 2001 the production of generic anti-retrovirals for HIV/AIDS sufferers reduced the cost of treatment from US$10 thousand per patient to US$350. The 20 year patent period obscures the aggressive pharmaceutical tricks, in what’s denounced as ‘TRIPs Plus’. These include a process called ‘ever-greening’ in which companies patent several constituent parts of the drug, increasing difficulties for generic producers, as well as legal opportunities to extend the patent period. These costs are worsened by the company’s use of the profits - contrary to advocates of patents - the funds for re-investment into new drugs is estimated to be less than 15percent, whilst pharmaceuticals make profits as high as 400 percent. The ‘Fortune 500’ list of businesses consistently places pharmaceutical companies as the highest earners. Issues with cost combine viciously with those regarding variety and efficacy. Whilst patents incentivise drug development, they are for the drugs with the highest returns; tropical diseases which account for 90 percent of deaths are not high earners. From 1975 to 1997 only 13 of the 1233 new drugs on the market were to combat these diseases. The United Nations has recommended (what they call) ‘diseases of poverty’ as a research priority but within the market system this simply isn’t possible. Evidently profits are not a suitable mechanism to address public health needs. Equally the hope afforded by the August 30 agreement has left many disillusioned being undermined by the system which begrudgingly conceded it. Despite opportunities for the least developed to claim high public need as a legal loophole for imports of non-patented drugs, it was only in 2007 that the first country took advantage, Rwanda. Rwanda applied to a Canadian based company for ‘Apo-TriAir’, a drug used by HIV/AIDS sufferers in what was deemed correctly by the government as a public health emergency. The restrictions for others were highlighted by NGO’s in a campaign called ‘A gift wrapped in red tape’, complaining the reforms were too cumbersome and vague. This reveals a larger issue, trade terms and reputation come before public health. In a globalised trading system countries reputations are paramount, adverse consequences to challenges of the patent system has prevented countries rightful applications, tentative attempts from Brazil, Thailand and Taiwan are illustrative. Often preventative terms are included in bilateral and multilateral trading agreements, such as the US and Chile. The system and reforms are failing consumers, it seems major decision makers are blind to the interests of their people. The effects are felt most severely by the poorest but not solely as has been shown by huge bills for Western countries stock-piling Tamiflu in light of the Swine Flu epidemic, a result of bans on imported generics. The issues are manifold and reform is equally complex and the three – yearly opportunity for reform has so far yielded little; the latest US proposed referendum only attempted to entrench existent issues and received only three votes. The UN special rapporteur for health asserted in June this year the need for TRIPs reform. He lambasted the agreement’s conflict with the right to health, calling for a simplification of clauses and an end to trade related pressures, however reform is not enough, people need change. This movement has grown since its support by two Nobel Laureates, Stiglets and Sulston. They demand a separation of research and development with production, and a private-public partnership. In their proposals government funds incentivise research and when new drugs become available there are no patents, allowing competition and reducing costs. Governments can also direct research to concentrate on the deadliest diseases; no trade manipulations, no ‘TRIP Plus’ instead responsible and affordable medicines, rights to health come with this responsibility. This is a major challenge as are many similarly unsavoury trading rules, the interests of the drug companies are well entrenched. It’s estimated that companies have spent US$3bn on political lobbyists in the US alone, with one senator commenting on the 2003 US Health Care Bill, “The pharmaceutical lobbyists wrote the bill”. However states need to act as legislation only strengthens, by 2016 it will be an obligation for all states to pass the bill. For the lady in Kampala it is too late, but a future of affordable drugs is a right for sufferers and a responsibility of policy makers, humanity needs to be put back into the rule book. philiprushworth89@hotmail.com