Biden presses Colombia to block biosimilar drugs

Posted on by James Love

vp_portrait.jpeg(More on Colombia here: /colombia)

On September 8, 2014, Vice President Joe Biden wrote to Juan Manuel Santos Calderón, the President of Colombia. In the letter, Biden registered a complaint about the regulations in Colombia to register biosimilar drugs. A copy of the letter from Vice President Joe Biden is available here, and includes this quote:

In order to deepen and expand our bilateral economic cooperation, we should maintain our focus on pressing matters of consequence to our trade agenda. Among these are the implementation of Colombia’s intellectual property rights commitments and sustained progress on the Colombia Labor Action Plan. We remain concerned about . . . the biologics decree, which the World Health Organization and US experts believe could put health and safety at risk. Ultimately, such discussions and policy differences should be understood as a result of our shared success and our desire to build on that success, and I am confident our governments can find a way to address these issues.

What is Biden referring to? This is how USTR has described the dispute, in the 2014 National Trade Estimate Report on Foreign Trade Barriers.

Colombia is considering new rules affecting the approval methodologies for biologic and biotechnologic medicines. The proposed draft decree would establish three pathways for the approval of biological medicines. The first two pathways appear to be aligned with World Health Organization guidelines as well as U.S. Food and Drug Administration (FDA) approval processes, and would permit biological medicines to be approved either: (1) on a stand-alone basis with a full dossier of supporting preclinical and clinical evidence (the Complete Dossier path), or (2) on the basis of a robust analytical preclinical and clinical comparison with a previously approved innovative biologic (the Comparability path). By contrast, the third pathway is an abbreviated pathway that does not appear to require the same detailed information and clinical evidence to prove the quality, safety, and efficacy of a product but would instead permit an applicant to rely on “any information deemed relevant” when the information originates from designated countries or specified health authorities abroad for a product with an “active pharmaceutical ingredient.” In July 2013, Colombia notified the fourth version of this draft decree to the WTO through the TBT Committee. The United States, the European Commission, U.S. stakeholders, and a Colombian patient safety group each submitted comments to the WTO expressing concern with the third pathway. Despite initial indications that the regulation might be reviewed and revised, the Ministry of Health and Social Protection continues to indicate that it intends to retain the third party abbreviated pathway. The United States will continue to engage with Colombia on this issue in 2014.

For context, the US approach to approval of biosimilar drugs is considered excessively stringent, and has discouraged the introduction of less expensive drugs.

In concrete terms, Biden is leaning on Colombia, to make it much more difficult to approve for marketing generic/biosimilar versions of biologic drugs, such as trastuzumab (trade name Herceptin), an expensive drug for breast cancer, or rituximab, an expensive drug used to treat both cancer and autoimmune diseases.

Vice President Biden’s wife Jill has had breast cancer, and runs a charity for breast cancer patients (one that has been funded in part by AstraZeneca, a company that sells treatments for breast cancer). One of the main consequences of the Vice President’s actions are to make it more difficult to obtain access to biosimilar traastuzumab, T-DM1, and other breast cancer drugs.

Note that from 2011 to 2013, the US FDA approved 9 new biologics drugs for the treatment of cancer, with an average cost per year or treatment of $128,452. (http://goo.gl/9NdpGj) The Vice President wants to make it more difficult for cancer patients in Colombia to have access to these cancer drugs.

FORA issues

BIO and its member companies have pushed the United States and the EU to engage Colombia on the regulatory issues in WTO discussions on technical barriers to trade. Interestingly, while BIO wanted Colombia to be selected for the USTR Special 301 Watch List (WL), the comments to USTR for the 2014 301 list, signed by Joseph Damond, did not mention the biosimilar regulatory policy as a basis for their request. Moreover, BIO did not even mention Colombia in its 2013 submissions for the 2014 USTR NTE report. PhRMA raised the Colombia biosimilar regulatory policy in its submission to the NTE Report, and briefly in its Special 301 submission. PhRMA asked that Colombia be subject to an out-of-cycle review in 2014.

One would have thought that the Technical Barriers to Trade Committee in the WTO would be a fora for complaining about excessive barriers to trade, but in this case, the US is arguing that Colombia’s regulatory regime is not restrictive enough. These concerns would be more appropriate if presented in the World Health Organization, where there is both the expertise and a mandate to address the regulatory safety concerns.

Background documents

Press reports:

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