Reshma Ramachandran and David Carroll warn that the Trans-Pacific Partnership will trample over access to affordable medicines
Last month, Wikileaks posted the complete Intellectual Property (IP) Chapter of the secretly-negotiated Trans-Pacific Partnership Agreement (TPP) confirming public health advocates’ worst fears of the agreement’s impact on patients worldwide. The TPP is the largest free trade agreement to date between the United States and 11 other countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam) comprising over 40 percent of global GDP. This landmark agreement is expected to “set the standard for 21st century trade agreements going forward.” While free trade agreements are designed to lower barriers for the importation and exportation of goods between countries and strengthen the global economy through mechanisms such as lowered tariffs, the TPP goes far beyond past traditional trade regulations with the inclusion of over 20 chapters on a variety of non-trade related issues including domestic food safety, health, labor, environmental policies. Two of these chapters on investment and intellectual property will have far reaching consequences on the public health of populations worldwide. The TPP has been shrouded in secrecy, with only the negotiators and an “advisory committee” of over 700 industry representatives allowed to read drafts of the agreement. Even congress and congressional staffers have been barred from examining drafts of this far-reaching agreement.
Since the previous leak of the IP Chapter in 2011, several professional and civil society organizations including Doctors Without Borders, American Association of Retired Persons, Public Citizen, and the International Federation of Medical Students Associations have sent letters and presented at the closed-door negotiating rounds to the United States Trade Representative (USTR) expressing concerns that the proposed provisions patients will severely restrict access affordable, innovative medicines. The Wikileaks posted text revealed that the USTR and Obama Administration have decided to aggressively prioritize the interests of multinational pharmaceutical and medical companies over patients worldwide and at home. In fact, according to emails submitted to Intellectual Property-Watch under the Freedom of Information Act, the USTR has actively solicited the input of industry groups, giving them special access to the negotiating text while consumer and health groups have had to resort to requesting special meetings with negotiators. The USTR is also one of the best examples of a revolving door between government and industry. Since the turn of the century, at least a dozen USTR officials have taken jobs with companies that favour stronger copyright and patent protection. Peter Maybarduk, Director of Public Citizen’s Global Access to Medicines Campaign, described meetings with US negotiators as, “…a complex diplomatic exercise, it’s not like a frank exchange of information about what is actually happening.”
Indeed, the recently leaked TPP chapter reflect these corporate interests as evidenced by the still-included provisions. In the text, the USTR has proposed a number of provisions that will further strengthen patents and data exclusivity for pharmaceuticals. Such provisions will bar the entry of generic competition into the market allowing for brand-name drug companies to retain their monopoly market and set drug prices at exorbitantly high prices. These provisions include:
Lowering patent standards allowing for “evergreening” or the granting of patents for newer forms of existing medicines including new formulations or minor modifications even in the absence of a therapeutic benefit
Mandating that surgical, therapeutic, and diagnostic methods must be patented making medical practitioners in TPP member states liable for infringement and restricting their choices for treatment
Imposing data exclusivity on all pharmaceuticals, including biologics with the minimum period for this class to be set at 12 years (despite the fact that the White House is publicly in favor of a 7 year data exclusivity period and the FTC has stated that there is no need for any data exclusivity period at all) thereby not allowing drug safety regulators from accessing clinical data to grant market approval for generic and biosimilar drugs
Adjusting patent term periods to account for “unreasonable delays” including patent prosecution periods ranging from two years to more than four years extra further delaying generic drug entry into the market
Adjusting patent term periods for regulatory approval periods allowing for patent extensions for both new pharmaceutical products as well as methods for producing or using new pharmaceutical products halting any potential innovation
Linking patent status and drug marketing approval causing drug regulatory authorities to take on the additional task of early patent enforcement, allowing for bogus patents to be a barrier to generic drug registration
Such proposals go beyond current U.S. and international law including the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Additionally, the TPP has the potential to jeopardize millions of lives in the participating countries by driving up the costs of medicines significantly. Even in the United States, there has been a public outcry from physicians regarding the high cost of medicines. Earlier this year, over 100 oncologists came together to write a perspective piece in the journal Blood calling the prices of brand-name cancer drugs “astronomical, unsustainable, and perhaps even immoral.” The United States health care system has in fact greatly benefited from the entry of generic competition. On May 9, IMS Health released a report entitled Declining Medicine Use and Costs: For Better or Worse?, which found that many Americans had forsaken much needed doctor visits, medicines, and other treatments as they struggled to afford health care. In light of this, it is appalling that U.S. negotiators would continue to push provisions that would further exacerbate the cost burden of healthcare for patients not only abroad, but at home.
The week following World AIDS Day, trade ministers will convene again in Singapore as a potential “end game” to the negotiations planning on making large trade-offs on various trade topics including copyright, Internet issues, and medicines in order to make a grand announcement that they “have a deal” by the end of the year. Despite opposition from both civil society and other TPP governments, the USTR is aggressively pushing the participating countries to accept these dangerous IP provisions during this meeting to finalize the agreement. The USTR recently claimed that the “United States is a leading voice for strong [intellectual property rights] protections and for access to medicines for the world’s poor, including in developing country [Trans-Pacific Partnership] partners”. These good intentions are admirable but are overshadowed by the actions of the USTR, as it continues to trade away health and true innovation to cater to Big Pharma profits. To keep the promise of an AIDS-Free Generation and the ability to provide access to affordable medicines, the trade ministers must put a stop to these harmful provisions at the upcoming Singapore meeting.
If you want to make a difference, you can write or tweet to USTR Michael Froman and tell him to stop attacking access to lifesaving medicines here. Organisations can write too and feel free to use our recently sent letter as a template.
Reshma Ramachandran is a joint medical and public policy student at Alpert Medical School at Brown University and Harvard Kennedy School. David Carroll is a medical student at Queen’s University Belfast .They can be found on Twitter @reshmagar and @davidecarroll.
Reshma Ramachandran is a member of the American Medical Student Association, the oldest, independently run association representing medical students in the United States and chair of its PharmFree Campaign, which advocates for ethical interactions between the pharmaceutical industry and healthcare professionals and academic medical centers.
David Carroll is involved in the student networks PharmAware and Medsin-UK, who both advocate for ethical interactions between the pharmaceutical industry and healthcare professionals. He is also co-founder of the Open Access Button.