India's soon to be taken stand on norms for data protection for pharmaceuticals and agrochemicals is likely to influence the decision taken by most of the developing countries now under pressure from the US led interest groups, say experts.
Apart from the US and EU countries, only a dozen odd countries have taken a concrete decision on allowing data exclusivity, so far. The Indian decision will not only act as a role model for many of rest of the developing world which are signatory to WTO to emulate, but also will determine the availability of affordable medicines in many of these countries in future.
They cite that at present many countries grant exclusivity for a period of time as data exclusivity provisions in the Trade Related Intellectual Property (TRIPS) agreement mandates WTO member-states to protect clinical data filed for marketing approval or registration of drugs. Except for countries like Brazil, Thailand, South Korea, Canada, Cuba etc. that denied allowing this provision for a fixed period considering their domestic interest, many other developing countries like Israel and South Africa have yielded to the pressure of the US led interest groups and multinational pharma companies.
India, China and Brazil are role models for most of the developing countries on issues like this. Of this, China yielded to the pressure tactics. Under the current Chinese drug administration law, test and other data submitted for marketing approval of pharmaceutical products, which utilize new chemical entities, cannot be used by the second party without the permission of the first party for a period of six years. Israel, a country with generic pharma interests, also has agreed not to disclose test and other data submitted for approval and not to publicize the data for public inspection. Though Brazil allowed data exclusivity for 10 years for agrochemicals, it declined to adopt data exclusivity for pharmaceuticals.
The US allows 5-year data exclusivity for five years for new molecular entities (NME), which bans generic launches in that country during the period. Further, the other US provisions include three-year data exclusivity for supplements requiring clinical trials and seven-year market exclusivity when the client population for a drug is less than 2 lakh patients for any single indication. Under the European Union laws, any members of the EU are allowed to adopt either a six year or a ten year data exclusivity period.
In Australia, five-year data exclusivity period is allowed for new products containing pharmaceutical actives approved after 17th March 1998, with exclusivity period beginning with date of approval. In Philippines, undisclosed test data submitted by an applicant for market authorization has to be protected as per the provisions in its Food, Drugs & Cosmetics Act. Under the Czech law on medicines, a six-year protection is given unless written authorization is not received from the registration holder.
In New Zealand, data exclusivity is allowed for a period of five years, though exclusivity is not allowed for data relating to new uses or formulations of old active ingredients.
Though Thailand does not allow exclusivity for a fixed period, as per its Trade Secrets Act, data submitted as a condition for marketing approval should neither be disclosed to a second applicant nor relied upon by the regulator. Own independent data has to be submitted to the regulator by other applicants. South African laws protect test data against 'disclosure and unfair commercial use'.
As per the provisions in South Korea, the Government is obliged to protect the test data, if the applicant requests not to disclose his data. However, the Government can reveal the data to the public, if the authorities feel there is need to disclose the information.
Similarly, though Canada allows five-year exclusivity period, if a generic manufacturer is able to establish the safety and efficacy of the product through BE/BA studies, permission may be granted considering the innovator's data.