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Biodiversity Law approves R $ 270 million for research

Postado em 9 de julho de 2015

The new rules for the operation of Brazilian biodiversity, approved by the Senate last week, should unlock up to R $ 270 million in research and development of new herbal medicines in the country. In the evaluation of the national pharmaceutical industry, the Biodiversity Act, which deals with access and use of genetic resources of animals, plants and micro-organisms Brazilian, sets clear standards for scientific research on medicinal plants and therefore enable the resumption of projects that were interrupted in the last decade due to the lack of regulation.

A survey of FarmaBrasil Group (GFB), established in 2011 to represent the Brazilian pharmaceutical industry research and innovation, indicates that at least 27 projects are shelved. Each development project in turn, consomeem average R $ 10 million.

“The new law eases the bureaucracy and encourages the use of biodiversity. Concerned about fines and excessive bureaucracy (arising from MP 2186/2001), companies stopped investing for years, “said vice president of GFB, Adriana Diaféria. The PLC 2, 2015, approved by the Senate, will return to the House of Representatives, which enjoy some adjustments made in the Senate, and then proceeds to presidential approval.

To encourage the development of drugs from medicinal plants, new legislation must also be reflected in expansion of participation of herbal medicines in national pharmaceutical market. According to the GFB, based on IMS Health data, these products still account for a very small market share, from 1.58% last year and 1.76% in 2013. In Germany, for example, drugs developed from of medicinal plants already account for 10% of the pharmaceutical retail sales.

In other numbers, the share in Brazil amounts to little more than R $ 1 billion – R $ 1.039 billion, more precisely – a total of R $ 66.971 billion in sales last year, continuing the verified loss of market share in previous years. In 2014, while the Brazilian pharmaceutical market grew 13.3%, shows the GFB survey, herbal sales advanced only 1.3%. The best-selling drug in this category was Tamarine a laxative Farmasa laboratory, with R $ 62.8 million.

In Hebron laboratory, which completes 25 years of operation in Caruaru (PE) this year, the expectation is large relative to the new rules. According to Josimar Henrique da Silva, founder of traditional laboratory in this segment, revenues from herbal medicines is expected to double in the next five or six years, from R $ 60 million last year. “More important than double revenue is to enter the closed club search. This is important for the country, “he said.

A few years ago, the Hebron went on to sell three items of their portfolio for Aspen Pharma, South Africa, and now, under the new legislation aims to accelerate the launch of innovative herbal medicines. “The greatest benefit of this project is the regulation. As to date the rule was not clear, the industry was impaired and stopped the exploitation of biodiversity in the last ten years, “he said.

The Biolab, which also stopped research on herbal medicines, the perception is that the new legislation brings important stimulus to the sector, such as allowing patent plant extracts. Under the new rules, the pharmaceutical want to resume six projects that were frozen in the areas of dermatology, allergy and nanotechnology in herbal medicine.

According to Dante Alário Jr., director of Biolab, today herbal represent about 4% of sales, but there is potential for growth. “With clear laws, the industry tends to further explore the possibility of integrated operation (such as the Hebron),” he added.

Among the major changes that will be established by the Biodiversity Act are the termination of prior approval by the Board of the Genetic Heritage Management (CGEN) to national organizations for research and development and the payment of 0.1% to 1% of annual net revenue obtained with the product developed based on Brazilian biodiversity from its market launch. The rule in force, no need for prior approval and benefit sharing agreement must be executed even without knowing if the product will be commercially viable.

(Source: Valor Econômico – 22/04/2015)

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