Remarks as Prepared for Delivery
I had the honor of speaking at the Partnership for Safe Medicines Annual Meeting in October in Washington, D.C. I’m delighted to see PSM expanding in Thailand.
The work that you do is enormously important. In fact, for many, it’s a matter of life and death.
The problem we face isn’t new but it does merit our continued focus. For most of the 19th century, medicines were neither safe nor effective. One of America’s leading physicians of the time and Dean of the Harvard Medical School, Oliver Wendell Holmes, Sr., commented that: “if all medicines in the world were thrown into the sea, it would be all the better for mankind and all the worse for the fishes.”
We cannot afford to return to this era. Making sure that our citizens have access to safe and effective medicines is a moral obligation that falls on all of us—companies, governments, and civil society.
This includes safeguarding supply chains from substandard drugs that do not meet quality control standards as well as counterfeit or fake medicines, which are intentionally designed to deceive consumers.
Stopping the spread of substandard and counterfeit medicines requires slightly different approaches but, regardless of terminology, unsafe medicines are just that, unsafe.
Counterfeit and substandard drugs impact both the developed and developing world. In fact, the distribution of fake and substandard drugs has been reported in over 100 countries. The United States—through, in large part, the tireless work of the FDA—takes great pride ensuring the safety and efficacy of our medicines. Yet we’re not immune to the threat of counterfeit and substandard drugs.
Last month, a fake supply of the anti-cancer drug Avastin that made its way into U.S. doctors’ offices and medical clinics. Once identified, the U.S. FDA immediately issued a warning to healthcare professionals and patients about the counterfeit drug and began an investigation. They acted quickly to protect lives. We cannot afford to ignore the threat of counterfeit and substandard drugs with the hope that the danger will magically disappear or go unnoticed.
That’s why raising awareness is the first component of the U.S. Department of State’s safe medicines strategy. Broadcasting the dangers of counterfeit and substandard medicines and, when necessary, details on specific fake medicines is critical to safeguarding our pharmaceutical supply chains.
Patients, health care providers, pharmacists, and other stakeholders need to be aware to be vigilant. We’re planning to use the winning public service announcement from today’s Safe Medicines Public Service Announcement contest to do exactly this.
Over the past two years, the State Department has funded 24 similar outreach efforts throughout Africa, Asia, Europe, the Middle East and South America. These public diplomacy projects rely on the involvement of health industry stakeholders, including educators, pharmacists, hospitals, industry associations, and foreign government officials.
Counterfeiters prey off the ignorance of the public. Our outreach projects bring together relevant stakeholders to make it harder for counterfeiters to sell their illicit wares.
The second pillar of our safe medicines strategy is focused on stopping counterfeiters themselves. These criminals sell their wares—be they tainted, ineffective, or poisonous—without regard for patients who may be harmed in the process.
We’ve funded a series of government-to-government training programs—in collaboration with other U.S. government agencies, the private sector, and NGOs—to help foreign law enforcement, customs, and judicial officials catch and prosecute traffickers of counterfeit medicines.
While many of these programs are part of our intellectual property rights or IPR crime training and technical assistance package, I want to stress again that counterfeit medicines are, first and foremost, a public health threat.
The enforcement of IPR is one legal mechanism we use to catch these counterfeiters. We need every tool available to confront increasingly sophisticated trans-national organized crime groups that have turned to counterfeit medicines as part of their criminal enterprise.
The third pillar of our safe medicines strategy is on multilateral engagement. Over 80 percent of the active ingredients for genuine drugs sold in the United States are manufactured abroad. A substandard batch in one country can adversely impact dozens of countries.
And, in the case of counterfeits—which, as I mentioned earlier, are deliberately meant to deceive—criminals capitalize on legitimate trade to sneak fake medicines across international borders. Therefore, a global approach is necessary to reduce the threat of counterfeit and substandard drugs.
That’s why, last year, as the Asia-Pacific Economic Cooperation (or APEC) host country, the United States led three dialogues on counterfeit and substandard medicines.
And, the United States is active in the World Health Organization, whose Executive Board recently adopted a package of recommendations on unsafe medicines.
These recommendations—which will need to be approved by the World Health Assembly in May—call for strengthened engagement on building regulatory systems for safe, quality, and rational use of medicines.
And, they establish a new mechanism for international collaboration focused on prevention and control of unsafe medicines.
Effective public health systems are critical to secure pharmaceutical supply chains from both counterfeit and substandard medicines.
Finally, within the Lower Mekong Initiative—which brings together the United States, Thailand, Cambodia, Vietnam, and Laos—the health pillar includes a concentration on combating counterfeit and substandard medications.
We recently brought drug regulators from all four Lower Mekong countries to Washington, D.C. for meetings with their U.S. counterparts.
The U.S. government—through the work of the State Department, USAID, FDA, and others—is using a number of different approaches to address the threat of counterfeit and substandard medicines.
We’re increasing awareness, helping build enforcement and regulatory capacity, and working through international organizations to develop global solutions.
As we continue these efforts, we’ll continue to work with our partners in other governments, in industry, and in the public sector.
Before concluding, I’d like to thank all of the contestants for their contributions to today’s Safe Medicines Public Service Announcement contest. Regardless of who wins, the fact that you entered fulfills our goal of raising awareness on the dangers of counterfeit and substandard medicines.