COSTA RICA
A RISKY BUSINESS: COUNTERFEITS AND PARALLEL IMPORTATION
María del Pilar López and Esteban Monge Zürcher Lawyers
Drug counterfeiting
To comprehend the dangers of becoming involved with counterfeit and parallel importation of pharmaceuticals, it is essential to understand all that the concept encompasses. According to the US Food and Drug Administration, a counterfeit medicine is a fake medicine that may be contaminated or contain the wrong, or no, active ingredient. It could also contain the right active ingredient but at the wrong dose.
According to statistics from the World Health Organization (WHO), all kinds of medicines are counterfeited, from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines. T e WHO also reports that up to 25 percent of medicines sold in developing countries are counterfeit and in some territories up to 50 percent of pharmaceuticals placed on the market are fake.
Parallel importation of pharmaceuticals
On the other hand, a parallel import is a non-counterfeit product that is imported from another country without the permission of
the IP
right holder. T e product is produced genuinely, under protection of a trademark, patent or copyright, placed into circulation in one market, and then imported into a second market without the authorisation of the rights holder. T is form of importation is permitted by law in many countries due to the international exhaustion principle. T is standard sets forth that, normally, rights are exhausted upon fi rst sale anywhere and parallel imports cannot be prevented, meaning that the IP owner cannot control the distribution or resale of the product.
T e idea is to allow distributors to procure drugs from cheaper international sources, so decreasing the prices of brand-name drugs. T is decrease is passed on to fi nal consumers and the saving may have a positive impact in developing countries where pharmaceuticals are sold in small volumes at high prices. Furthermore, the threat of accessing parallel import drugs may be suffi cient to provide health providers enough negotiating infl uence with
56 World Intellectual Property Review e-Digest 2013
www.worldipreview.com
INDIVIDUALS AND ENTITIES THAT ARE LEGALLY ENGAGED IN PARALLEL IMPORTATION OF
PHARMACEUTICALS MUST FOLLOW A SERIES OF BASIC RULES TO ENTER THE TERRITORY OF A SPECIFIC COUNTRY.
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