Under Secretary Robert Hormats talks about international outreach to fight fake drugs
Bob Hormats, Under Secretary of State for Economic, Energy and Agricultural Affairs was the luncheon speaker at the Partnership for Safe Medicines 2011 Interchange.
Below is a transcript of Under Secretary Hormats remarks.
I’m delighted that you asked me to speak today. The work that the Partnership for Safe Medicines is important. Making sure that our citizens take safe medicines is not just good for business, it’s a public health issue, and it’s a moral obligation that falls on all of us—companies, governments, and civil society.
With that in mind, I want to talk about three areas to consider in our fight against counterfeit and substandard medicines: Collaboration, China, and Confidence.
Collaboration
It’s apropos that my friend and colleague, FDA Commissioner Peggy Hamburg addressed this group last year because it highlights the fact that to curb the spread of counterfeit and substandard medicines we need collaboration. Collaboration within the U.S. government, collaboration between governments themselves, and collaboration with the private sector and, indeed, all stakeholder groups.
That’s why the State Department is funding a number of government-to-government anti-counterfeit medicines programs. The goal here is to help foreign law enforcement, customs officials, and prosecutors and judges catch and convict criminals involved in counterfeiting medicines. This funding is part of our IPR crime training and technical assistance package. The issue of counterfeit medicines is, first and foremost, a public health threat. We use IPR as a legal mechanism to catch counterfeiters. Capacity building and technical assistance training is delivered by USG inter-agency teams composed of enforcement officials from the Department of Justice, Patent and Trademark Office and Department of Homeland Security, with team composition tailored to the training task. U.S. private sector business and civil society stakeholder experts have also be invited to participate in a number of programs.
We also collaborating to increase global awareness of the problem through public outreach programs that are managed by our embassies. These public diplomacy projects rely on the involvement of health industry stakeholders, including educators, pharmacists, hospitals, industry associations and foreign government officials. And—working with the FDA—we’re bringing drug regulators to the United States to receive training on drug quality control, monitoring, and counterfeit and substandard drug detection. This is raising public awareness and improving the prosecution of counterfeiters.
In addition to these bilateral programs, this year, as the Asia-Pacific Economic Cooperation or APEC host country, the United States led three dialogues focused on counterfeit and substandard medicines. One of which was a seminar on detection technologies for counterfeit medicines that was held in Beijing in September.
The location for the seminar was strategic and leads me to my second topic—China.
China
Over 80 percent of the active ingredients for drugs sold in the United States are made abroad, mainly in Chinese facilities. It’s obvious that China has to be a focus.
When it comes to China we need to first improve their overall regulatory systems. That’s why the U.S. Food and Drug Administration is working with their Chinese counterparts to raise their mandatory Good Manufacturing Practices or GMP requirements to meet international standards. This will help the Chinese both protect public safety and help domestic industries move up the value chain.
We also need to stop diversion of active ingredients into the grey market, that is, the shadowy network of counterfeiters. These are criminals that don’t care about a patient’s health when selling fake, tainted, poisonous, or sub-standard forms of life-sustaining medicines. For this we’re using reputation as a hook.
I just returned from a trip to China where I addressed the U.S. – China Pharmaceutical Summit. I had a chance to meet with aspiring biotech innovators, generic drug manufactures, and regulators. The Chinese want move up the pharmaceutical value chain. I explained that to do this, the Chinese government and companies to show leadership. It’s essential that they work toward a culture in which problems are not swept under the rug but rather, are openly discussed.
Counterfeit, falsified, and substandard medicines are not a hypothetical problem. The results can be tragic. You all know that in the United States, 81 patients died from contaminated Heparin in 2010. There have also been reported deaths in China due to counterfeit and sub-standard medicines as well. Hence, we’re working with the Chinese to build confidence in their pharmaceutical industry amongst their own citizens.
Patient and industry confidence is the third and final topic that I wanted to raise today.
Confidence
Patient confidence is a theme that we’re thinking about globally, particularly given the interconnectedness of the pharmaceutical supply chain.
For most of the 19th century, drugs were neither safe nor effective. One of the leading physicians of the time and Dean of the Harvard Medical School, Oliver Wendell Holmes, Sr., famously 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. We must ensure that our citizens—in their most desperate moments—have confidence that the medicines they are taking—or that their loved ones are taking— are safe and effective.
Experts report that there has been a 700 percent increase in drug counterfeiting from 2002 to 2009. It’s not just life-style drugs that are being counterfeited. In 2009, we identified counterfeited versions of over 800 unique medicines, ranging from antibiotics to cardiovascular drugs to anti-cancer therapies.
Securing the pharmaceutical supply chain continues to be one of the most difficult obstacles to overcome in the battle against counterfeit medicines. Technological solutions in the form of track and trace technologies, detection technologies and mobile technologies have started to help break through some of the obstacles. Such technologies are becoming increasingly available as useful tools for enforcement and regulatory authorities. The private sector will need to show leadership in embracing these technologies to secure their reputations and patient confidence in the pharmaceutical industry.
The Internet and the growth of online pharmacies has also complicated matters. Consumers have a hard time differentiating between legitimate and illegitimate online pharmacies. Through the leadership of my colleague Victoria Espinel, the White House Intellectual Property Coordinator, the private sector has voluntarily agreed to address rogue online pharmacies responsible for distributing illegal pharmaceuticals in the United States. And several internet and credit card companies have stepped forward to support efforts to educate the public and start taking voluntary enforcement action against illegal Internet pharmacies.
I began today by talking about collaboration. Criminal enterprises are more nimble than government bureaucracies, making it difficult to completely shut down an enterprise once discovered. They move on and set up operations elsewhere. Even if caught, weak enforcement and justice systems with inconsequential penalties fail to create the level of deterrence that could have a meaningful impact. This is why all stakeholders need to collaborate to help build consumer confidence and protect the health and well-being of our citizens.
Thank you.