TEST DATA PROTECTION IN PERU
"Data test protection is constituted by information resulting from tests conducted with a novel molecule, which have determined the efficacy and safety of it"
Data test protection is constituted by information resulting from tests conducted with a novel molecule, which have determined the efficacy and safety of it.
Decision 486 of the Andean Community provides the ability to protect this information in terms of exclusivity. It also allows each country member the choice of whether or not to include these periods of exclusivity in their territory.
Also, Legislative Decree No. 1072 provides for the protection of data tests in the registration process of a new chemical entity (NCE) for a period less than the validity period of a health registration, that is, less than five years, counted from the date it was granted the registration in Peru or from the first commercial approval worldwide, for the case where the registration is based on such an approval.
During the aforementioned period, the registrant shall enjoy the right to exclude any person from the use of test data or other undisclosed information submitted for the approval of the health registration. The same rule also states that a NCE is a biologically active fraction responsible for the physiological or pharmacological action of an active ingredient, which at the time of application for licensing has not been included in medical records previously granted in the country.
Similarly, the decree states what cases will not be considered to be NCEs:
- Different therapeutic uses or indications from those authorised in other previous sanitary registrations of the same chemical entity or combinations of known chemical entities.
- Changes in the way of administrating it, in the dosage, in the modifications in pharmacokinetics, in the dissolving time and in the bioavailability, authorised in other previous sanitary registrations of the same chemical entity.
- Changes in pharmaceutical forms or in formulations of chemical entities already registered.
- Salts (including salts with hydrogen bonds), esters, ethers, complexes, chelates, clathrates, isomers, metabolites, co-crystals, polyphorms, solvates, pure forms, particle sizes, prodrugs, or those chemical structures notwithstanding their forms, disposition or expression that are based on a previously registered chemical entity.
- The combination of an already known chemical entity and a new one.
It is also worth mentioning that in Peru, the commercialisation of certain products such as food and cosmetic products is subject to regulation by the state, for which the competent authority issues a health permit based on the filing of certain information which describes the product. The health authority carries out a verification of its ingredients, components and laboratory test results, in order to certify that these products do not contain toxic elements that create potential risks to the health of consumers.
For the case of agrichemicals, the test data corresponding to information about the safety and efficacy of a NCE serve to verify that they do not represent any risk for farmers, consumers, or the environment. In Peru, these data are required by the health authority in order to issue the sanitary registration of chemical pesticides for agricultural use, which gives permission to market the product nationwide.
Sanitary registration is approved following a risk-benefit assessment, carried out by the administrative authority, which includes compliance with the legal and technical requirements established by the Andean Community.
Until now only 18 applications for test data protection of NCEs have been approved in Peru, because the process of developing a new drug is very complex and demands a great scientific and economic investment, which begins at the moment of selecting the potential candidate molecules for development, from thousands with potential therapeutic action. Therefore, the protection of test data does not mean a monopoly but an incentive for countries that have developed this research.
Finally, it is important to clarify that the test data protection is not a way of extending patent protection. They are different legal institutions that can perfectly coexist in time.