Indian Generic Pharma Warns Against Government Caving To US Pressure On Data Exclusivity

The Indian Drug Technical Advisory Board meeting on 7 November is expected to discuss a measure that could lead to opening the way to a 10-year data exclusivity period for originator pharmaceutical companies in India, according to the Indian Pharmaceutical Alliance. The alliance submitted a letter to the advisory board to warn against consequences on public health of data exclusivity if the Indian government “succumbs to” pressure by the United States.

In a letter to the Indian Drug Technical Advisory Board dated 27 October, D G Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), explained why data exclusivity, which extends market exclusivity, would delay access to cheaper versions of the medicines.

At issue is Rule 122E (Definition of new drug) of the Drugs and Cosmetics At of 1945, which states that “a new drug shall continue to be considered as [a] new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia whichever is earlier.”

The discussion to take place tomorrow, which considers extending this period to 10 years, could be a “back-door entry” to data exclusivity, according to Shah. The Drug Technical Advisory Board, which operates under the Ministry of Health, has recommendatory powers only, he told Intellectual Property Watch.

According to the letter, all regulatory authorities require the first applicant – usually the innovator – for regulatory approval of a new medicine, to submit data on the safety and efficacy of the new drug. The generation of this data is costly and includes testing in animals and human clinical trials.

Usually, the subsequent applicants for approval are only required to establish equivalence with the previously approved drugs and are exempted from producing data on the safety and efficacy of the generic drug, it said.

Governments can decide to prohibit the unfair commercial use of the data by competitors and provide for protecting the confidentiality of the data submitted. Some governments may decide to provide the first applicant with market exclusivity in recognition of the expense incurred in generating the data on safety and efficacy, the letter said, adding that such periods of exclusivity typically range between 5 and 10 years.

“Data exclusivity can be granted for new drug products irrespective of whether they have patents or not and the period of exclusivity starts from the date of regulatory approval. No generic drug can be approved during the period of data exclusivity resulting in a monopoly for the new drug product, separate and distinct from the monopoly resulting from patents.”

“Unlike in the case of patents which can be challenged as invalid, data exclusivity cannot be challenged,” Shah said in the letter.

Data exclusivity only benefits a handful of originator pharmaceutical companies but would be harmful for the pharmaceutical industry in India, according to the letter. Requiring generic applicants to generate their own preclinical and clinical data of safety and efficacy is completely “untenable”, it further says. Awarding market exclusivity to a single manufacturer would impact access to medicines at affordable prices for patients, Shah added.

According to Shah, in the letter, data exclusivity extends market exclusivity and does not translate into increased foreign direct investment, and delays the entry of generic medicines.

The letter also reproduced the recommendations of the the 88th report [pdf] by the Parliamentary Standing Committee on Commerce on data exclusivity. The issue of data exclusivity also arose in 2015, when India was considering its legislation on pesticides (IPW, Public Health, 26 March 2015).

The recommendations, as reproduced, stated:

“As a condition for registering pharmaceutical and agro-chemical products, National authorities normally require the applicant to submit data relating to quality, safety and efficacy of the product. The Committee were informed that the MNCs[multinational corporations] are demanding ‘Data Exclusivity’ on their data, so that its use could be prevented for allowing generic manufacturers to take marketing approval. The Committee is aware of the fact that there is considerable pressure on the Government to accede to this demand. The Committee feel that conceding to demand for Data Exclusivity would amount to agreeing to TRIPS plus provisions [Editor’s Note: TRIPS is the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights]. Once such a demand is agreed at bilateral forum, there will be additional demands, which may relate to higher level of intellectual property right, such as extension of patent period, restriction on compulsory licences, restriction on parallel imports, and may be on R&D activity on patented subject matter. Data Exclusivity may result in delay in ensuring role of domestic enterprises through compulsory licensing system, and in preventing other parties from developing similar data.”

“Since the consequences of Data Exclusivity are quite serious, the Committee strongly recommend that the Government should not fall prey to such demands of MNCs. The Government must thwart such attempts, being made at the behest of certain vested interests. It should also guard against moves to enter into FTA with USA, as the developed countries, particularly the USA, are trying to bring in certain TRIPS Plus measures through Bilateral and Regional Agreements.”

 

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