GPhA comments on generics’ legislation and Trans-Pacific Partnership

Generics/General | Posted 09/01/2015 post-comment0 Post your comment

Mr Ralph G Neas, President and CEO of the US Generic Pharmaceutical Association (GPhA), has commented on proposed legislation for generics in the US, as well as on provisions in the Trans-Pacific Partnership that he believes could impede access to medicines.

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Mr Neas believes that legislation being proposed in the US ‘reflects a basic misunderstanding of the pharmaceutical marketplace, and attempts to impose brand pharmaceutical provisions on generic drugs.’ This, according to Mr Neas, is ‘misguided’ and could ‘threaten patient access to affordable medicines’.

He points out that generics saved US$239 billion in 2013 (a 14% increase in savings from 2012) and more than US$1.46 trillion in the last 10 years. Furthermore, since 2008, the price of brand drugs has almost doubled, but the price of generics has almost halved.

The GPhA believes that the best way to increase access to medicines and lower prices is to encourage competition and points out the following ways the US Congress can foster competition:

  • Encourage the timely FDA review of the more than 3,000 generics applications filed with the agency. Approval will increase patients’ options, driving down prices
  • Increase scrutiny of the misuse of safety programmes designed to protect patients that are instead being used to thwart competition from generics. A recent study estimates this costs the US healthcare system US$5.4 billion

The GPhA has also expressed its concerns over intellectual property negotiations taking place as part of the Trans-Pacific Partnership (TPP) agreement.

The TPP is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the US and Vietnam.

The GPhA believes that the treaty is taking ‘an unbalanced approach to intellectual property protection that will impede access to safe and affordable medicines’. Mr Neas states that ‘trade agreements should promote competition and allow US generics companies to enter markets where there is great potential for growth’. Adding that ‘using intellectual property protections to create new barriers to entry for generic medicines would threaten the growth of US exports and jobs’.

This is not the first time the TPP has been accused of hindering access to medicines. Proposed provisions in the TPP for 12 years of biologicals exclusivity have also been criticized [1].

Related article
Access to generic medicines undermined in free trade agreement

1.  GaBI Online - Generics and Biosimilars Initiative. More debate over the exclusivity period for biologicals in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from:

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Source: GPhA

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