Chemical Technology May 2015

COVER STORY

tortuous not only by the existing regulations but also by the slow process of change in the regulations, for example, the Colourant regulations which prescribe which colourants may be used in foodstuffs in South Africa have not been updated comprehensively for about 20 years with the result that the table of permitted colourants does not include any natural colourants, with the absurd result that artificial colourants are permitted in your food but natural colourants, such as those produced by physical concentration processes of fruit and vegetables are not permitted. Thus, innovators who see a gap in the market and spend their time and effort to satisfy the demand are prevented fromcommercialising their innovative ideas, such as processes for producing natural colourants for foodstuffs, until the long and winding road of amending the Colourant regulations is finally completed. Even in research the long red tape is there to trip up the unwary, for example, the Intellectual Property from Publicly Funded Research determines who owns any intellectual prop- erty which arises from co-operation with a publicly funded institution and thus the unwary innovator co-operating with a university may find at the end that he does not own the intellectual property in respect of his own innovation as under this law the university does! It is a sad fact of our system that patent attorneys, al- though highly qualified by being required to hold both a degree in science or engineering and a law degree and to pass many qualifying examinations before being admitted to practice, are not trained in understanding and assisting their clients in overcoming the regulatory hurdles which stifle innovation and which to the writer is just as important as protecting the invention if the innovator is to be able to commercialise and monetise the innovation. Having identified this gap of the approaching regulatory tsunami and its effect on innovation, the author has set up a team at Hahn & Hahn which is able to assist its clients in understanding and overcoming the regulatory hurdles. If you are an innovator who is experiencing these frustrations, then remember to contact the writer (on janusz@hahn.co.za or www.hahn.co.za). to help you navigate the regulatory maze and to protect your innovations and inventions.

do so, to say the least, and would be very difficult for most small companies or lone innovators to do so. However, this permit, the Discovery Phase permit, only per- mits the search for and indexing of the indigenous biological resource but not any further research or commercialisation thereof. In order to conduct further research or to com- mercialise any indigenous biological resource or a product thereof, a Commercialisation Phase permit must be obtained by each link in the chain of research and development and commercialisation thereof. This means that it is not simply a matter of obtaining a Commercialisation Phase permit by the party that discovered it under a Discovery Phase permit, but each research organisation, manufacturing entity, wholesaler, and so on, must have its own permit for the commercialisation of the indigenous biological resource. To complicate matters further, the requirements for the obtaining of these permits are very onerous and, for example, require the identification of the indigenous people who may have been using said indigenous biological resource, entering into a benefit-sharing agreement with them, and the applica- tion to the Department of Environmental Affairs for a permit – all before any research or commercialisation can take place. The result of the above regulatory environment on bioprospecting is that many small businesses are simply ignoring it and continuing illegally which puts them at risk of prosecution, but also prevents them from obtaining patent protection for their innovation, since the Patents Act requires that permits and benefit-sharing agreements be in place be- fore a patent can be applied for. These smaller businesses, and some large ones, either are not aware of the onerous regulatory requirements or are simply unable to comply due to a lack of skills in dealing with such complexity which falls outside their core field of business. Another example of how innovation is being stifled by regulation, is the Foodstuffs, Cosmetics, and Disinfectants Act which has numerous regulations associated with it, many of which are based on existing technology and entrench that which has already been approved, thereby making it very difficult to introduce new and innovative ingredients in food manufacture. The path to innovation is made more

Janusz F Luterek, PrEng Tel: +27 (12) 342 1774 Email: janusz@hahn.co.za www.hahn.co.za

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Chemical Technology • May 2015