US House Democrats have urged President Barack Obama to keep the issue of data exclusivity for biologic drugs out of the next round of Trans-Pacific Partnership (TPP) talks, set for next month.
The Patient Protection and Affordable Care Act (PPACA), which Pres Obama signed into law last year, creates an approval pathway at the Food and Drug Administration (FDA) for generic versions of biologic drugs - also known as "biosimilars" - which would provide 12 years' data exclusivity for the originator products.
But the Obama Administration wants this exclusivity period cut to seven years, and has included this in its budget proposal for FY2012.
In a letter to the President, House Democrats led by Henry Waxman state that, as the US prepares to propose text on intellectual property [IP] rights concerning pharmaceuticals for the seventh round of TTP talks, due to take place in the US in September, "we strongly recommend that the United States refrain from negotiating any provisions related to exclusivity for biosimilar medicines."
The biosimilars pathway has only recently been established, so the consequences of the mandated 12 years' exclusivity are not yet known, nor has the FDA promulgated any regulation to implement the PPACA's provisions for biosimilars - or yet approved any such products, they say.
Proposing 12 years' exclusivity in the TTP talks would conflict with the Administration's FY2012 budget proposal, writes Rep Waxman - who has introduced legislation to limit the exclusivity period to five years only - and he also reminds the President that his budget proposal states that seven years' exclusivity rather than 12 "would achieve an estimated $2.34 billion in savings over the next decade."
The TTP is a multilateral free trade agreement which the US is currently negotiating with Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam. If the finally-agreed version deal were to include 12 years' exclusivity for biologics, this "would impede the ability of Congress to achieve the Administration's proposed seven-year change without running afoul of US trade obligations," the Democrats warn the President, adding: "we see no reason for the United States to agree to such a provision, much less to propose it."
But the industry is keen for the TTP to include the 12 years' exclusivity. If it does, it will be the first US trade agreement to do so, because others such as the KORUS deal with Korea were agreed before the PPACA was signed into law.
In its comments on the TPP's proposed chapter on IP, the Pharmaceutical Research and Manufacturers of America (PhRMA) says: "the recent passage of a 'biosimilars regulatory pathway in the United States recognised the importance of data protection and the evolution of the innovative biopharmaceutical industry. Protection consistent with US law - ie, at least 12 years for biologics and at least five years for non-biologics, with adjustments to be made for future indications, is essential."
"Data protection is distinct from patent protection and is particularly important where the means to enforce patents are not readily available, and thereby provides on of the few incentives to launch and expand access to new medicines as rapidly as possible in developing-country markets," says PhRMA.
The industry group also points out that at the end of July, a bipartisan group of 40 Members of the House wrote to the President urging him, in the course of the TPP negotiations on IP rights, to support current US law on biologics.
"The US-led biopharmaceutical industry would be disadvantaged if the US does not ensure consistency with US law as part of the TPP, because foreign countries do not provide the same type of protection rules," the legislators warn the President.
They remind him that the current protections for biologics were "debated extensively and receive strong bipartisan support in both the House and the Senate," and add: "this provision is critical to keeping and expanding high-value US jobs offered by America's biotech sector and spurring the R&D investment needed to seize extraordinary opportunities for medical advances to combat our most costly and challenging diseases."
- After the seventh round of TPP negotiations in the US next month, an eighth round is set for October in Peru. The participatory nations are aiming to have a basic agreement on the deal by November.