Biopiracy fear incites Pharma “Dutch Disease”

It’s been half a millennium since European visitors first came to Brazil, in pursuit of its mineral and agricultural riches. Jesuit missionaries also discovered huge wealth in the “drogas do sertão” or back-country remedies such as sarsaparilla, guaraná, or urucum, all widely used in early medicine.

Fears that foreign “biopirates” were stealing these riches – especially those from the Amazon – have for centuries provided an important thread to the national psyche. In some isolated cases – such as the illegal removal of rubber tree seeds by British explorer Henry Wickham in 1876 – those fears were justified. Mostly they stoked isolationism and prejudice.

"Drogas do Sertão" were precursors of medical trade

“Drogas do Sertão”  exploited by forteigners were precursors of the medical trade – and old  suspicions live on

But in recent years the nationalist sounding-box of Brasilia’s congress has worked on both deep fears and laudable sentiments of protecting patrimony to create draconian federal legislation that has spawned bureaucracy and regulation helping to shut down much research activity, in the name of protecting plant-based riches and traditional knowledge from pillage by foreigners.

The effect has been perverse, contributing to Brazil’s current pharmaceutical “Dutch Disease.” This is a huge consumer market, yet Brazil is poor in patents, while its own industry focuses on low-tech generic medicines rather than real innovation or treating tropical diseases. Lawmakers, it seems, would rather see the Amazon forest burn than its pharmaceutical riches be developed.

Occupying ninth place globally (according to Deloittes), Brazil in 2013 spent US$26.4 billion on pharmaceutical drugs. But leading sectors of the pharmaceutical industry are dominated by multinationals, while local companies responsible for much of the 7-10% annual market expansion (according to McKinsey) have focussed on generics.

Coincidence or not, a paper published by the US National Institutes of Health, found that despite huge efforts by Brazilian scientists (who published over 10,000 papers on medicinal plants between 2011 and 2013) the practical results were irrisory. “In spite of the abundant Brazilian biodiversity and the thousands of academic publications on plants in international peer-reviewed scientific journals, few patents and medicines have been derived from such studies,” said the report authored by Dutra, Campos, Santos and Calixto.

Nice to look  at:  but collecting Amazonian cocoa-pods is "biopiracy." (foto SFB)

Nice to look at: but collecting Amazonian cocoa-pods is “biopiracy.” (foto SFB)

They continued: “Despite the large Brazilian biodiversity, notably with the higher plants, which comprise over 45,000 species (20-22% of the total worldwide), and the substantial number of scientific publications on medicinal plants, only one phytomedicine is found in the top 20 market products. Indeed, this market is still only worth about 261 million American dollars. This represents less than 5% of the global Brazilian medicine market.”

A key impediment is the 2015 Biodiversity Law (Law 13.123) introduced by former president Dilma Rousseff, and which replaced interim legislation dating back to 2001. The Law (on the state book since 2016) is designed to preserve both plants and the knowledge of their uses in traditional medicine, from being exploited to create patents internationally, without payment of royalties.

The law stipulates that any research involving Brazil’s “genetic patrimony” (PG) or traditional knowledge and lifestyle (CTA), must be registered with the federal government. Regardless of whether any proposed research into PG or CTA has any commercial intention or not, scientists must register themselves with an official body named SisGen, (national archive for management of genetic patrimony and traditional associated knowledge.) All studies relating to ecology, taxonomy, epidemiology, plus genetic sequencing of any plant, animal or microbial tissue or micro-organisms whether by land or sea, must be registered.

To ensure that traditional knowledge that may have given – or at some future date may give – rise to any commercially-valid pharmaceutical preparation is financially rewarded, the law creates a National Benefit Sharing fund (FNRB) into which patent holders must pay according to a complex legal formula. Legal experts warn that if ethnobotanists have been exposed to traditional knowledge of plants by “attending markets, reading publications or lists, seeing films, scientific articles, registers or any other catalogue of traditional knowledge,” they are legally liable for future payments. Warns intellectual copyright lawyer Isabella Katz Migliori from Gusmão & Labrunie law partners: “It’s possible to get hold of traditional knowhow without ever having left the laboratory.”

Don't ask  what medicinal teas she brews up in the kitchen. You might  have to pay royalties ( Foto SFB)

Don’t ask what medicinal teas she brews up in the kitchen. You might have to pay royalties ( Foto SFB)

Once registered as agents, scientists retain legal and financial responsibility for any samples they extract or send for testing either in Brazil or overseas. And the legislation is retroactive too, obliging any scientist who between 2000 and 2015 may have sent samples overseas for testing to provide full details by November 2017.

Swingeing fines of up to R$10 million for individual researchers make noncompliance ruinous. No wonder senior academics such as Thaysa Paschoalin, head of biosecurity at the Department of Environmental Security at Sao Paulo’s federal university Unifesp, are concerned about the implications for professional academics. “We must  mobilize to make  people aware of the scope of this law,” she warns  scientists, “in order to minimise the legal  sanctions to which we are now  subject.”

This is hardly the only embarrassment inflicted upon serious scientists by Brasilia’s politicians. In 2016 then-president Rousseff signed a special decree exempting a home-made “cancer drug” (synthetic phosphoethanolamine) from supervision by the national regulatory agency, because over 15,000 sufferers had signed legal papers demanding access to the untested chemical brewed at university labs in São Paulo.

However laudable the Biodiversity Law’s intentions – and however much genetic material and traditional knowledge of medicinal plants may in the past have been spirited away – the Law 13.123’s current curbs are neither serving to advance science or commerce. Nor is it helping Brazil fulfil its potential as a drug discovery destination.

It should stand to reason (as the NIH article postulates) that Brazil, with its combination of world-leading plant diversity across several biomes, indigenous and rural traditions rich in ethno-pharmacological lore and at least two centuries exposure to western science, would be a world leader in drug discovery.

In fact 50.4% of the world’s drugs are derived from natural products and derivatives (rather than petrochemicals). And microbe-derived genetic material is now fuelling the biotech industry.

Researching  this critter's genetic makeup could land scientists with a big  fine (foto SFB)

Researching this critter’s genetic makeup could land scientists with a big fine (foto SFB)

After all, the treasures of established international pharmaceutical empires are still plant-derived. Morphine (a painkiller), erythromycin (an antibiotic), cyclosporine (an immunosuppressant) and artemisinin (an anti-malaria drug) are some examples. So too is paclitaxel, a chemotherapy drug derived from the bark of the Pacific yew tree (Taxus brevifolia).

A diaspora of Brazilian scientists has fanned out across the world’s research universities, seeking cutting edge research opportunities not available at home. So now Brazilian policymakers must bring some of this precious knowledge back home – if they can. In November the Second Workshop on Recent Advances in the Chemistry of Natural Products, hosted by the FAPESP Research Program on Biodiversity Characterization, Conservation, Restoration and Sustainable Use (BIOTA-FAPESP) at FAPESP São Paulo headquarters.

However, in an increasingly polarised political atmosphere caused by the run-up to the 2018 elections, unravelling the perverse effects of Law 13.123 will be hard. Creating a truly open environment for drug research in Brazil, is almost as difficult as removing the underlying distrust of foreigners and their interest in Amazonia. Meanwhile, Brazil’s biodiversity – and the fast-vanishing traditional knowledge of its pharmacopeia – is threatened by agribusiness, industrialisation and aggressive urbanisation.

This  view of  Amazonia's plant riches could prove  costly  for unregistered  scientists (Foto SFB)

This view of Amazonia’s plant riches could prove costly for unregistered scientists (Foto SFB)

 

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