Concerns raised over NAFTA biologic data proposal

A proposal in the North American Free Trade Agreement (NAFTA) to set the length of biologic data exclusivity at ten years would harm patients, according to generic associations.

The Association for Accessible Medicines, the Canadian Generic Pharmaceutical Association, and the Mexican Association of Generic Medicines shared their concerns about NAFTA’s renegotiation on Tuesday, August 28.

NAFTA, a trade agreement between the US, Mexico and Canada, is currently being renegotiated. However, the preliminary agreement on data exclusivity and a range of other issues has only been reached by Mexico and the US so far.

The associations that shared their concerns each seek to improve access to safe and effective medicines in their respective countries.

One of the areas being discussed is the number of the years that brand name biologic data protection lasts for.

The agreement preliminarily agreed upon by the US and Mexico this week includes “at least” a ten-year data exclusivity period for biologic drug makers.

This would be higher than the figure that was being negotiated in the separate and now-defunct Trans-Pacific Partnership trade agreement (between five and eight years).

That agreement is now being renegotiated without the US.

“The announced trade understanding between the US and Mexico to extend brand name biologic data protection to ten years will harm patients who seek more affordable medicines,”  the associations claimed.

They explained that the biosimilar industry provides price competition to expensive prescription drugs, allowing patients to benefit from affordable medicines.

As such, provisions “which would benefit brand name drug companies to the detriment of public health and the affordability of medical care” should be rejected by the NAFTA signatories, the associations said.

This is not the first time these concerns have been raised; the associations asked their governments not to raise drug prices by extending brand name monopolies in the NAFTA renegotiations last October.

Last month, the US-based Leadership Council of Aging Organizations also warned that changes to the price of pharmaceutical products in the revised NAFTA agreement “could undermine access to affordable medicines”.

The interest group said it would oppose any revision which forces countries to allow ‘evergreening’, monopoly protections, or anything else used to block the entry of generic drugs on the market.

In June, AARP, another US-based group focusing on the interests of people above 50, similarly urged the US Trade Representative not to include provisions in NAFTA that would reduce competition in the prescription drug market and increase the cost of prescription drugs.

AARP noted that biologics are “the future of pharmaceuticals”, but their high cost often makes them inaccessible.

Any prospect of the US’s current 12-year data exclusivity period for brand name biologics being incorporated into NAFTA is “greatly” concerning for AARP, which supports lowering the exclusivity period to seven years.

In January, more than 100 organisations expressed concerns over NAFTA’s IP chapter.

International groups including Oxfam and Doctors Without Borders urged Canadian, Mexican, and US health ministers against expanding “monopoly protections of prescription drug corporations” which thwart market competition.

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