- Medicine Access and Rational Use > Financing
- Traditional Medicine > Traditional, Complementary and Herbal Medicine
(2001; 88 pages)
8.1.1 The law
The following are the most salient features of Costa Rica's Biodiversity Law:
In Costa Rica, it was decided to include the protection of traditional knowledge and the practices, innovations and knowledge of indigenous and local communities within the scope of the access legislation. This means a link was made between access legislation and the protection of traditional knowledge. So Costa Rica has opted to include, in its access legislation, the following resources: wild resources; cultivated or domesticated resources39; marine resources; terrestrial resources; ex-situ resources; in-situ resources; intangible components, such as indigenous and local communities' knowledge, innovations and practices; chemical and biochemical resources (note: Article 15 of the CBD only mentions genetic resources, but Costa Rica also included chemical and biochemical resources, which are important for the pharmaceutical industry). And, finally, derivatives or products derived from any of these resources are included.
39 There is a debate about the need for different approaches and procedures for agricultural genetic resources, as well as an on-going debate at the FAO regarding the re-negotiation of the International Undertaking on Plant Genetic Resources.
Related, and equally important, are the exclusions. The Costa Rican law excludes: (i) human genetic resources40 - this has important consequences for pharmaceutical research; (ii) biological resources not used as a source of genetic information - it is important to differentiate between a fruit used as fruit or a fruit used as a source of genetic information, and to clarify that access and benefit sharing legislation deals exclusively with the use of the genetic information contained in the biological resources; and (iii) customary and traditional use.
40 Since the Second Conference of the Parties in Jakarta, the CBD also excludes human genetic resources.
Another important issue is: who decides, who is the competent authority in charge of granting permits. Options include central authorities, local authorities, advisory committees, etc. In addition, there is a need for an assigned, specific focal point; in Costa Rica, this focal point is the Ministry of Environment and Energy.
benefit sharing terms
At the national, regional and international level, the concrete terms of benefit sharing are probably the most contentious issue. Some of the options are: upfront payments; royalties; fees for materials and services; involvement of local researchers and communities in collection and in R&D; the use of local academic research institutions and universities; milestone payments. Further possibilities include training of local researchers and students, technology transfer to local institutions, licenses to manufacture and market commercial products, provision of commercial drugs at cost price, assistance with development programs e.g. in the area of health or education or legal assistance, joint ventures in activities of local interest, translation of information and reports, etc. While not specifically mentioned in the law, all of these possibilities have arisen and have been used in Costa Rica.
Procedures are another important issue. Irrespective of whether one uses contracts, permits, access agreements, material transfer agreements etc., it is important to establish legal certainty and to ensure transparency. To achieve this, a public register may be created, but if so, a balance should be found between openness and the right to confidentiality; usually, confidentiality is one of the companies' most important demands in negotiations.
In addition, it may be advisable to establish different access procedures for agricultural purposes, for pharmaceutical purposes etc., since the objectives, as well as the prevailing terms and conditions, are different. Similarly, procedures for commercial research and scientific research should be different, in order to avoid that access legislation interferes with basic research; omitting to provide for differential procedures is probably one of the most common mistakes. Finally, material transfer agreements for ex-situ collection should also be considered.
Obviously, provisions for sanctions and penalties -monetary or otherwise- and for appeal are needed; these are the regular and normal parts of any law.