On January 17 2009, the regulations of Legislative Decree No 1072 regarding the "Pharmaceutical Test Data Protection and other undisclosed data of pharmaceutical products" were published in the Peruvian gazette, El Peruano.
The aforesaid decree protects a kind of information designated as "Test Data", which is used for determining the safety and effectiveness of a pharmaceutical product. In order to obtain said protection, it is required that the generation of the test data has involved "considerable efforts".
Likewise, the health authority in Peru, the General Direction of Medicines and Drugs (DIGEMID), requests the filing of such test data as a condition for obtaining a health registration of a pharmaceutical product containing a new chemical entity. This test data will be protected against the disclosure and use by a third party.
The protection term of pharmaceutical test data is five years from:
- The date when the registration in Peru was granted; and
- The first approval of commercialisation in another country and the approval of it in Peru within six months.
The pharmaceutical test data protection cannot be requested independently, but only during the health registration procedure.
Moreover, said data must be filed only in the case that the health authority requests it, and provided that the pharmaceutical product contains a new chemical entity that is not included in any other health registrations previously granted in Peru. Thus, it must have territorial novelty.
This matter has been controversial, since the intellectual property aspects of medicines was one of the most critical points of discussion in the negotiations of the Free Trade Agreement between Peru and the US. The fact that this regulation allows multinational pharmaceutical companies to enjoy a term of five years of protection regarding information filed before DIGEMID is considered by some to be a restriction of the commercialisation of the generic version of a brand name drug.
In our opinion, five years of protection cannot be justified as a means of encouraging the investment that the pharmaceutical companies make for obtaining new drugs, as they already have a 20 year term of protection granted by the registration of the drug as a patent.
Another interesting point in the discussion is whether the new regulation will cause an increase in drug prices. This possibility has been consistently rejected by the Peruvian authorities, but subject matter specialists have affirmed that it will inevitably occur. However, the Peruvian authorities have affirmed that the cost of generic versions of pharmaceuticals that are presently provided by the social insurance and public hospitals will not be affected.
Finally, there are many points that have not yet been sufficiently clarified in the current regulation, including the meanings of terms such as "considerable efforts" and "5-years normal protection period".
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| Lilie C Delion and Freddy Rodríguez |
Estudio Delion
Las Acacias 898, Urb. Las Palmeras
Los Olivos, Lima 39, Peru
Postal address
PO Box 27-0044, Lima 27, Peru
Tel: +51 1 523 9147 / 522 0360
Fax: +51 1 521 0685
lcd@estudiodelion.com.pe
www.estudiodelion.com.pe