UNITAID assesses potential implications of the Trans-Pacific Partnership agreement

The executive summary of the forthcoming report, “Trans-Pacific Partnership Agreement: Implications for Access to Medicines and Public Health,” is available here [pdf]. The report has yet to be published.

UNITAID is an international organisation hosted by the World Health Organization, that works for “greater access to treatments and diagnostics for HIV/AIDS, malaria and tuberculosis in low-income countries.”

The report will analyse the effect of specific provisions from the chapters relating to intellectual property, regulation of pharmaceutical reimbursement schemes and investment. These chapters were leaked to the public in 2011 and 2012, but the summary notes that “long as the negotiations are ongoing, the text may evolve and change.”

Senior legislators from most of the countries involved in the TPP negotiations have openly called for the draft text to be made available to the public. Their statements are available here.

“The analysis in this report supports the view that the TPPA, if adopted, will have major implications for public health and access to medicines,” says the summary.

UNITAID expressed concerns about the TPP in November. “Many of the agreement’s provisions still under discussion could significantly affect access to medicines through hampering generic competition if adopted,” UNITAID Executive Director Denis Broun said in a statement at that time.

Public Health-Related TPP Proposals

The TPP proposals for patents include lowering disclosure requirements and standards, and broadening the scope of patentable articles to include surgical and diagnostic methods. This is likely to lead to “a greater number of weak or ‘poor-quality’ patents,” says the summary, and doctors being restricted from, or having to pay royalties for, employing certain methods of diagnosing or treating diseases.

UNITAID also says that the proposals tilt in favour of patent applicants by removing the possibility of signatories to allow pre-grant opposition, and weakening the Bolar provision, which allows generics to get approval for their products before the patent expiry in order to quicken entry into market.

Proposals on data exclusivity may require generic companies to conduct costly clinical trials, after the original drug has been approved, for copies of both patent and off-patent products. This has the potential to delay market entry, and the summary points to “unethical” issues related to duplications of trials. It also requires signatory states to implement harmful patent linkage systems, which has the “well documented” effect of delaying generic market entry.

Provisions on trademarks may cause confusion in patients and cause more errors in prescription and distribution of medicines, says UNITAID. And copyright provisions have the potential to restrict parallel imports and extend rights over products after patent expiry.

Enforcement provisions will make it more difficult to challenge poor-quality patents, increase interim injunctions against generics and increase the risk of seizures of legitimate generics, it says. Players in the making and distribution of generics may also be deterred by “debilitating” punishments proposed for trademark infringements.

UNITAID also said the TPP proposals could limit the control that government will have over the activities of foreign investors, and will allow investors to challenge states for their actions with regard to health related IP and regulatory policies in investor-state settlement disputes.

Alternative Actions

UNITAID proposes alternative “policy options for developing countries to ensure that trade or commercial interests do not hinder the protection of health and human development.”

It supports a “positive agenda” whereby policies help to achieve “long term, affordable and sustainable access to medicines.”

Developing countries need credible empirical “evidence to inform policy-makers and strengthen their position in trade negotiations.” UNITAID invites analyses of the impact of free trade agreement changes in IP policy on public health.

It also states that IP regimes should be supplemented by, and balanced with, protective measures for anti-competition, to support public health.

Source: Intellectual Property Watch