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Drug patents, International Conflict and Your Best Interest (Oh My)

Years ago Brazil went out on a limb and “Stole” medicine (patents) and delivered end product to their population.  When we think about patents that have a significant implication to the world, at what point does recouping development costs and making a little profit become overshadowed by long term corporate greed and our planets / populations best interest?

The argument is simple enough.  If companies that invest and develop drugs are not compensated then these ideas will never be created and those who need the medicine will never receive it. This possibly used to be true but it is no longer a fact.

A person who used to work for the largest of drug companies shared with me that it often costs a company up to Two Billion Dollars to bring a new drug to market.  Granted, these costs also include the research to find out if the new drug would cannibalize any of the existing medicine revenue they currently sell.

Case in point- this same company researched creating their own brand of Cannabis / THC and discovered that besides not being able to create a ‘Unique Product’ that what they did create showed higher than acceptable percentages of pregnant women having ‘Ecstatic Births’.  Can’t have that! Think of all the meds our hospitals feed our mothers and how much money that generates.  Not to mention that the United States is among the LAST on the list for healthy births for developed nations.  “The Business of Being Born” does a great job of explaining the downward drug loop that precipitates this unfortunate fact.

So what can be done?  The idea is simple enough; Open Source Drug Development.  Allow for meaningful co-development to occur and credit those who have impact on the end result.  Spread out the costs, leverage the brain power of the ‘Crowd’ (reference Ted Talk: Of oxes and the wisdom of crowds: Lior Zoref at TED2012).

Collaborative research is now longer outside our abilities.  I imagine we will begin to see this type of research done as plant based medicines ( which may not provide the revenues necessary to sole source research ) still provide critical efficacy.

CBD (Cannabidiol) is a good example candidate.  ( PS: The U.S. Federal Government has the patent on Cannabidiol. )

The below is the referenceable point that inspired this idea.

The average annual cost of ART per patient in 1997 was $4,459—compared to over $10,000 in most of the developed world—totaling only $242 million per annum.[17] However, in 2001, Brazil manufactured locally 8 of the 12 drugs in the national ARV cocktail; in 2003 and 2005, 8 of the 15.[18][19] If all of the drugs were patented imports, the cost of these ARV programs would increase by 32%.[17] In the period between 1996 and 2000, Brazil reduced treatment costs by 72.5% through import substitution; by contrast, the price of imports dropped by only 9.6%.[18] Brazil has save over US $1.1 billion in the cost of providing universal access to ART by producing anti-retroviral medications generically [20]

Article 71 of the 1997 Brazilian patent law requires that foreign products be manufactured in Brazil within three years of receiving a patent. If a foreign company does not comply, Brazil may authorize a local company to produce the drug without the consent of the patent holder, a tactic known as “compulsory licensing” or the “bargaining chip and as a last resort.”[21] In addition, Article 68 authorizes “parallel importing” from the lowest international generic bidder, effectively destroying the patent holder’s monopoly as well.[22]

Prodded by domestic pharmaceutical lobbies, the U.S. challenged Article 68 within the framework of the World Trade Organization‘s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) regime for allegedly discriminating against imported products; Article 71—to the chagrin of many companies—was not included in the complaint. In additional, the U.S. placed Brazil on the “Special 301” watch list, opening the possibility for “unilateral sanctions,” and companies individually threatened to pull out of the Brazilian market altogether.[23] Brazil argued that the law only applied to cases where the patent holder abuses their economic power, a loophole specifically allowed by the TRIPS agreement.[18] Advocates of intellectual property rights (IPR) worldwide condemned the actions of the Brazilian government. For example, Slavi Pachovski, a member of the Institute for Trade, Standards and Sustainable Development, argues:[24]

If this trend proceeds, it will be a global pandemic of AIDS that will grow uncontrollable because the Brazilian move will destroy the whole legal order that is the basis for developing new drugs and continuing research.

The pharmaceutical companies were not just afraid of the immediate loss of the Brazilian market, but with the larger implications of other developing countries following Brazil’s example. Large developing countries, like Argentina and India, with large industrial capacities and evolving intellectual property regimes are the true elephant in the room.[25]