How Proposed TPP Regulations Stand in the Way of Patient Access

Drug access for millions of patients could be hampered under the intellectual property terms proposed by the Trans-Pacific Partnership (TPP). The TPP, a proposed trade agreement between 12 countries, will influence 40 percent of the world’s global trade when finalized and, in each of the signing countries, elements such as intellectual property regulations will become law for the duration of the agreement. In its current form, the TPP would provide expanded patent protection for some of the most expensive drugs being produced, meaning these drugs would not face competition from other producers.

More specifically, the proposed terms in the TPP would expand the United States’ drug patent protection of 12 years to all TPP partners. This patent exclusivity means that during this time, no other drug producer can create a product to compete with that medication. While periods of patent exclusivity exist in other TPP countries, none are as long as the U.S.’ of 12 years, meaning this provision of the TPP would lengthen patent protection for biologics and specialty drugs in all 11 of these countries. Ultimately, this expansion will prevent expensive branded drugs from facing market competition, ensuring prices remain high and the drugs stay out of reach for many patients with chronic or life-threatening diseases.

The U.S. and Japan have been the strongest supporters of these intellectual property regulations, but it has faced its fair share of criticism from patient advocates. Proponents of the current form of the TPP claim that because biologics require significant investment and long development periods, they require lengthy exclusivity periods. Without them, they claim innovation would be stifled. However, we have seen that the effects of these long exclusivity periods far exceed “recouping research costs.”

In 2010, Medicare Part B spent more than $8 billion on the biologics that make up eight of its top ten most costly drug regimens, and drug prices keep increasing. From 2013 to 2014, prescription drug spending in the U.S. soared from 2.5 percent to 12.6 percent, according to a recent report from the Centers for Medicare & Medicaid Services (CMS). Competition for costly biologic drugs is needed to ease the burden on global healthcare systems and patients.

The stakes are incredibly high for millions of people seeking care. The biologic market has proven itself to be robust, innovative, and profitable, but now patient access needs to be a priority for governments. The TPP will impact countries without healthy payer systems, and excessive exclusivity periods will effectively prohibit patient access to specialty medications that could save their lives or relieve chronic conditions. Because of the profound impact the requirements will have on millions of people for years to come, we urge world leaders proceed with caution and consider the far-reaching impacts of this agreement.