Trade agreement could be a bad deal for medicine
By Anna Zelivianskaia, M4
Chicago Medicine, February 2016
In the middle of a busy emergency room, a resident tells me, “I just found out how much a brand-name proton pump inhibitor costs – a 400 percent markup from generic and a few pills cost over $200!” Unfortunately, this is nothing new. And, in my opinion, the problem will only worsen under what’s known as the Trans-Pacific Partnership (TPP) trade agreement. The TPP was negotiated between the United States and 11 Pacific Rim countries, and now awaits congressional approval. Based on the final text, which was released in November 2015, the TPP will negatively impact public health in the signatory countries, including the U.S.
Harmful provisions in the TPP would loosen patent requirements, prolong pharmaceutical monopolies, and tighten intellectual property regulations. Longer brand-name monopolies translate into limited generic usage. This is particularly worrisome for developing countries with less access to generics drugs.
According to Public Citizen’s Global Trade Watch, “The TPP would set the parameters” for future efforts by national and state legislatures to reduce the cost of medicines, protect public health and the nation’s fiscal health. Just one critical example: The TPP’s limits on future policy could shut down high-profile reform efforts, first and foremost, for Medicare Part D price negotiation.
Impact on biologic medicines
The most controversial TPP medicine-related provision concerns biotech drugs, or biologics – medical products derived from living organisms, Public Citizen states on its website. “Biologics include many new cancer treatments, now averaging around $190,000 per person per year. Most health systems cannot pay such prices without compromising other health care priorities. In the TPP, the pharmaceutical industry achieved its goal that every TPP country must provide new exclusivity periods for biologics.”
Provisions like these are particularly dangerous in a time when the face of poverty is changing and health care is becoming less affordable. Médecins sans Frontières (MSF) translated as “Doctors Without Borders,” relies mostly on generic drugs to treat many diseases – 80 percent of antiretroviral medicines used by the organization are generics.
In its early years, MSF worked mostly in low-income developing countries. However, poverty now exists and grows in countries with greater overall wealth. MSF today works in over 30 countries with incomes that are categorized as “middle” or “high” by the World Bank. Millions of people will be considered poor in TPP-participating countries once their country reaches middle- or high-income status.
For countries participating in the TPP, patent laws would be relaxed; it would be possible to patent a newer version of an existing medicine even though it has no new therapeutic benefit. The TPP would also extend current patent terms, which are usually 20 years, by five years if the company faces loosely defined “regulatory delays” during the patent process. In certain cases, individual governments can make medicines more affordable in their countries through price controls or reimbursement policies, but the TPP would also restrict the participating countries’ ability to alleviate health care costs using these techniques.
According to an MSF spokesman, “Data exclusivity blocks competing firms from using previously generated clinical trial data to gain approval for generic versions of these drugs and vaccines. If pharmaceutical companies have their way, the TPP will block generic producers of biologics from entering the market for at least 12 years.”
The argument for such regulations is that pharmaceutical companies need time to recoup costs lost during the development process; profit promotes innovation. However, the Federal Trade Commission found no evidence to support this and concluded that no years of exclusivity were necessary to promote innovation in biologic drugs. These regulations limit access to life-saving medications for the most underserved patients.
The TPP was negotiated using “fast-track” authority, which means that the final agreement is subject to a straight up-or-down vote by Congress, with little opportunity for debate or amendment. Most trade negotiations require this “fast-track” approach because other countries are unlikely to participate in negotiations if the final deal could have substantial changes or stall during the approval process.
As health care professionals, we have a responsibility to advocate on behalf of our patients. I believe that our efforts across the world will be severely limited if there are restrictions on affordable medications. And because of these threats to public health, I have written to Congress and President Obama to let them know I oppose the TPP.
Anna Zelivianskaia is a fourth-year medical student at the University of Illinois at Chicago.