Access to Medicine
The Phillipines Imposes Control over Prescription Drug Prices
An article from The Wall Street Journal stated that President Gloria Macapagal Arroyo of the Phillipines has announced the imposition of controls over prescription drug prices, which is a first in the country’s history. Below is an excerpt from the article.
Drugs and Manila
The Philippines’ imposition of price controls
The Wall Street Journal
OPINION ASIA
JULY 28, 2009, 12:30 P.M. ET
The war on intellectual property has a new front: the Philippines. Yesterday President Gloria Macapagal Arroyo announced the imposition of price controls on drugs for the first time in the country’s history. This might make for good politics, but it’s bad economics.
Mrs. Arroyo’s executive order mandates drug companies cut the price of five medicines by 50%. Health secretary Francisco T. Duque III said last week the five were chosen based on criteria including importance to public health, comparative pricing, “lack of market access” for the poor and “limited competition” with generics. Pfizer, which makes branded drugs for four out of the five medicines named, will be hit hardest.
This vaguely defined measure sends a terrible signal to foreign investors. Manila has provided no evidence to suggest that any of the medicines included in yesterday’s order-which include a standard antibiotic-aren’t available to people who need them, or available more cheaply in generic form. At the very least, the Department of Health should release exact guidelines of how the drugs were chosen and why 50% is such a magical number. Why not 60%? Or 80%? Why not mandate drug companies give their inventions away for free?
The real problem with Philippines health care isn’t high drug prices. Most Filipinos don’t buy branded drugs for cancer, heart disease and the flu. Rather than beat up on multinationals, Manila would be better served tackling health-care delivery problems at home. The Philippines, for instance, is one of the few countries in Asia that taxes drug sales. Manila could lower prices immediately by removing that levy.
Read more about prescription drug prices in the Phillipines.
To Import or Not To Import Pharmaceutical Drugs
That is the question that many of our lawmakers are asking. Senators Dorgan (D-ND), Snowe (R-ME), McCain (R-AZ) and Stabenow (D-MI) brought that question to the forefront when they introduced the "Pharmaceutical Market Access and Drug Safety Act of 2009" (S. 525 ) in March. Currently waiting to be placed on the Senate calendar, the bill would allow for prescription drug importation.
While a good-intentioned idea, the Partnership for Safe Medicines (PSM) believes that "Pharmaceutical Market Access and Drug Safety Act of 2009" will undermine nearly two decades of drug safety policy. Throughout the past 16 years and under two administrations, no HHS Secretary—Democrat or Republican—has certified a drug importation plans—a clear indication of the extreme safety concerns associated with drug importation and the challenges with ensuring safety of the globalized drug supply.
Unfortunately, this legislation simply does not recognize the increasing vulnerability of the international supply chain. In fact, it would allow importation from several countries that have had recent problems with counterfeit drugs in their own country. In the past three months alone, the Medicines Health products Regulatory Agency (MHRA)—the British equivalent of the U.S. Food and Drug Administration (FDA)—has issued two recalls for counterfeit insulin pens and inhalers . The European Union’s 2007 pharmaceutical counterfeiting data shows that almost 40 percent of fake medicines seized by the E.U. originated in Switzerland. And according to the Pharmaceutical Security Institute (a member of the Partnership for Safe Medicines), last year, there were 104 reported incidents of counterfeit medicines in Japan, while Germany and Austria were in the top 10 countries where counterfeit drugs were most frequently seized or discovered.
Any time consumers are subject to drugs from outside of the U.S.’s currently closed drug supply chain, there is a very real risk to their health and welfare. Foreign pharmacies are not subject to the FDA’s jurisdiction and the exporting countries’ equivalents of the FDA are not going to spend their limited resources scrutinizing drugs not earmarked for their citizens. It is both impractical and not their legal responsibility. Additionally, criminals continually use European parallel importation and trade laws to slip counterfeit drugs into the legitimate supply chains of member countries that allow it, such as the United Kingdom. Finally, there is no evidence that drug importation provides any real savings according to the Congressional Budget Office and independent academic analysis.
Read the rest of this entry on importing drug safety policy here.
Partnership for Safe Medicines Letter to President Barack Obama
April 8, 2009
President Barack Obama
1600 Pennsylvania Avenue, NW
Washington, DC 20500
Dear Mr. President,
On behalf of the Partnership for Safe Medicines (PSM) , a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines and dedicated to the safety of the drug supply, I would like to congratulate you on your efforts to improve health care and expand meaningful coverage for the millions of Americans who lack it. However, PSM is deeply concerned that the most vulnerable run the highest risk of encountering counterfeit, adulterated, or unsafe medicines and believe a comprehensive approach is needed to solve this patient safety problem.
We believe that safety must be our top national priority in any health reform effort. However, with respect to prescription drugs, today Americans unknowingly risk death or serious injury to their health by taking counterfeit drugs. Counterfeit drugs impact virtually every country in the world (including 115 in 2008) and virtually every disease state. Indeed, in 2008, there were at least 651 different types of counterfeit branded, generic and over-the-counter drugs discovered. Over the last several years, with improved appearance and packaging, these criminals have made their fake goods even harder to detect.1 This is clearly a growing global problem and requires many new types of international collaboration for effective investigation and interdiction.
Issue: Importation
In addition, this drug safety issue also has particular relevance to the debate on prescription drug importation into the U.S., one of several proposed cost-saving measures under consideration by Congress. I applaud your administration’s choice to study the issue before proceeding and would ask that any analysis focus upon several areas, including:
1. Lack of Regulation for Products Trans-Shipped Through "Safe" Countries such as Canada and U.K. Drug importation advocates believe that drugs purchased from countries such as Canada and the UK are safe because of their strict health regulations. Unfortunately, this is simply not true. For example, Health Canada clearly states drugs not earmarked for Canadians are not subject to the Canadian government’s safety regulations. Hence, drug exporters can bypass Canada’s safety regulations and mail fake or low-quality drugs made in high risk countries such as China and India to Americans without Health Canada’s oversight. Likewise, the UK indicates it lacks the power to stop suspected counterfeits on its shores destined for the U.S. because these goods are only transiting through the country. Indeed, recent conflicting E.U. rulings have resulted in U.K. customs now not stopping nor inspecting goods transiting through, allowing counterfeit medicines to move through the U.K. and into the U.S. undetected.
2. Inability for Importation to Satisfy US Demand and Foreign Provider and Citizen Resistance. There are simply not enough legitimate drugs in foreign supply chains to satisfy U.S. demand. For example, if just half of elderly Americans shifted their purchases to Canadian sources, it would exhaust the entire Canadian drug supply in a few months. Hence, both Canadian providers and citizens oppose U.S. importation. In addition, this reality could have considerable impact for our political and economic relationships with smaller countries like New Zealand, Czech Republic, Romania and others, whose supply could be devastated by parallel traders exporting most of their supply to the U.S.
3. Inaccurate Safety Perceptions for Foreign Risky Purchases. A drug importation policy will give Americans an inaccurate—indeed, dangerous—perception that buying drugs from any "Canadian pharmacy" is safe because "the government is allowing drug imports." This is particularly true for patients buying drugs through high-risk Internet drug sellers.
4. US Policy in Hands of Foreign Governments. Congressional importation proposals would place our drug policy in the hands of foreign governments. Price, quality, oversight (or lack thereof), and other critical issues will be defined by other governments without concern for U.S. patient protection and with unclear potential for safety regulation or enforcement. It would also reduce security of the supply chain to the weakest global link. The U.S. would effectively rely on the Asian, Baltic, and Balkan region countries to serve as our “border patrol” against counterfeit drugs. However, these countries do not have sufficient knowledge or capacity to do so and will prioritize the needs of their own citizens with the scarce regulatory resources they have.
5. Virtually No Cost Savings. The Congressional Budget Office estimates in its 2004 drug importation issue brief that reduction in drug prices from importation would be "small" or "only about 1% … [and] permitting importation only from Canada would produce a negligible reduction in [drug spending." Any savings would be virtually nonexistent because middlemen will reap all the profits and leave little, if any, savings for consumers. The reality is that prescription drugs from a safe, secure drug supply chain—regardless of whether or not it allows drug importation—will always be more expensive that those from an unsecured, potentially fraudulent supply chain.
Proposed Policy
Considering these risks, we urge you to educate Congress about the need to guarantee the safety of prescription drugs. This affects all of us, but our most vulnerable patient populations, such as minorities, seniors and fixed income patients would bear the brunt of any policy failure. Instead, we need to focus on creating substantive programs that maintain access to safe medicines by using the closely regulated and inspected U.S. supply chain. This could include:
1. Offshore FDA Support and Authority. The FDA needs funding and authority to develop programs and systems that tighten the drug supply chain. In order to stop counterfeit drugs and other unsafe products from pouring out of foreign manufacturing facilities and into the U.S., the FDA needs to establish more foreign field offices and staff them with both inspectors and criminal investigators armed with the same authority as their State-side colleagues. This includes the authority to enter and inspect foreign manufacturing facilities without previous notice.
2. Onshore FDA/Agency Support and Authority. The U.S. currently has 300 custom ports of entry, but the FDA only has 200 port inspectors and only 17 inspectors to cover all international mail centers. We must hire more inspectors here and grant the FDA and other agencies the authority to destroy unapproved and counterfeit drugs entering the US rather than returning them to the criminals who sent them here—our current policy.
Read the rest of this entry on prescription drug safety here .
Opinion: When Is a Pandemic Not a Pandemic?
The World Health Organization has backed itself into a corner on its Pandemic Influenza Phases system and the so-called swine flu. WHO knows it and is working on bureaucratic escape routes. But the real problem is what these alert systems mean for national governments that have detailed pandemic response plans — particularly the United States.
Read the rest of this article here .
U.S. Senate vote deferred on drug importation measure
A U.S. senator on Monday said he dropped plans to try to add a measure allowing importation of lower-priced medicines from other countries to tobacco legislation after being told the Senate will consider the drug issue separately.
Democratic Senator Byron Dorgan said that Majority Leader Harry Reid had promised to bring the drug importation measure to a Senate vote “very soon.” Dorgan said he expected the vote to happen within “a matter of a couple weeks.”
Last week, Dorgan said he planned to offer the importation measure as an amendment to a pending bill that would grant the Food and Drug Administration power to regulate cigarettes.
Read the rest of this article on drug safety here.
Diamonds Are Forever. Why Not a Drug Patent?
Carl Weissman 5/29/09
Tell me if this makes sense to you:
—If I buy a diamond, I can own it for as long as I like;
—If I produce a brand name for a product, provided that I trademark it, I can own it for as long as I would like, until and unless it becomes “generic” (like the term “escalator”, which actually started as a brand name);
—If I write a novel, provided that I copyright protect it, I can own it until I die, and my heirs can maintain those rights for 70 years longer; but,
—If I invent a drug, even if I protect that intellectual property to the full extent of U.S. patent law, I can only own it for 20 years from the date I file for a patent on it.
I can own a tangible good forever, I can own a trademark virtually forever, I can own a copyright for my entire life plus 70 years. But property which is more intrinsically a part of me – my idea, my invention, the product of my intellect – I am only allowed to own that for 20 years after I reveal it to the patent office.
Rationally, it seems obvious that all property – whether tangible or intellectual – should be subject to the same rules and laws of ownership. If you can own a gemstone forever, you should be able to own an invention forever. In fact, if a society wishes to impose differential standards for ownership rights to different types of property, wouldn’t it make more sense that preferential treatment be given to those items which are the product of your talent, your creativity, your self, over those things which you earn or purchase based upon that product of your efforts? The logical extension of this argument, in any free society, is that you should be able to own all property, whether purchased or invented, physical or ethereal, for as long as you wish. Patents, trademarks, copyrights, title – all should be perpetual.
Read the rest of this article on drug patent laws here.
Partnership for Prescription Assistance Prepared To Help Washington Workers Hurt by Recession
Spokane, WA – The ‘Help is Here Express’ bus tour will be stopping in Washington throughout the week of June 1st - 5th at various cities in order to help uninsured and financially-struggling Washingtonians access information on programs that provide prescription medicines for free or nearly free. With the state’s unemployment rate now hitting 9.1 percent – and having steadily risen for two years – the Partnership for Prescription Assistance (PPA) bus tour is raising awareness of patient assistance programs among state residents who face layoffs and loss of health care benefits.
The PPA, a nationwide effort sponsored by America’s pharmaceutical research companies, provides a single point of access to more than 475 patient assistance programs that help those who are uninsured or struggling financially. Nearly 200 of the programs are provided by pharmaceutical companies.
Read the rest of this article on prescription assistance programs here.
NIH Announces New Program to Develop Therapeutics for Rare and Neglected Diseases
The National Institutes of Health (NIH) is launching the first integrated, drug development pipeline to produce new treatments for rare and neglected diseases. The $24 million program jumpstarts a trans-NIH initiative called the Therapeutics for Rare and Neglected Diseases program, or TRND.
Read the rest of this article here.
Promoting HIV Prevention as We Seek a Vaccine
Ambassador Mark Dybul, Former U.S. Global AIDS Coordinator
Co-director, O’Neill Institute for National and Global Health Law, Georgetown University
Today, on HIV Vaccine Awareness Day , we pay tribute to all those contributing to the pursuit of a safe, effective and affordable vaccine against HIV. Much progress has been made globally to advance prevention, treatment and care because of the leadership, commitment and talent of leaders from all sectors in-country at the national, community and individual levels. However, with support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) , the Global Fund to Fight AIDS, Tuberculosis and Malaria and the UN family though the co-sponsors that make up UNAIDS , we have only just begun. We cannot reach the ultimate goal – an HIV Free Generation – without a safe and effective vaccine.
The U.S. is the global leader in HIV vaccine development. Biomedical researchers in our nation’s world-class laboratories are funded by the pharmaceutical and biotech industries, the U.S. Government (which provided approximately 80 percent of public expenditures for HIV vaccines), and foundations, most notably the Bill & Melinda Gates Foundation . In addition to basic research, clinical research physicians are leading HIV vaccine studies, volunteers are enrolling in clinical trials, and the community voices are advocating for funding and partnerships to reach the goal of an AIDS vaccine. All deserve our recognition and appreciation.
Twenty-five years ago, the U.S. Health and Human Services Secretary predicted an AIDS vaccine would be in ready for testing in two years. Another 20 years and numerous promising HIV vaccine candidates have come and gone. The past year was a difficult one, but that is the natural arc of scientific advance. We have learned much, and from that learning we continue the movement and momentum to find a vaccine. Now is not the time to back away because we do not have a vaccine – now is the time to redouble our efforts because we do not have a vaccine.
But without an unanticipated technological breakthrough, realistically, it will be years – 5, 10, or maybe another 20 – before we have an HIV vaccine. Meanwhile, we are still facing over 7,000 new HIV infections every day around the world. We know how HIV is transmitted and despite difficulties in measuring the success of specific programs, we know that HIV prevalence rates can drop dramatically. Recently, Namibia reported a nearly 50 percent decline in HIV rates among 15-24-year-old persons, following previous reports of 30 percent reductions in Kenya, 23 percent in Zimbabwe, and an overall reduction in Africa.
So we don’t need to wait for a vaccine to prevent HIV infections –there are proven strategies and evidence-based approaches that can dramatically reduce the transmission of HIV today. Education and behavior change including delaying sexual debut, partner reduction – both casual and multiple concurrent - and use of condoms, counseling and testing, prevention of mother-to-child transmission, male circumcision, post-exposure prophylaxis and the rapid expansion of treatment that contributes to decreased transmission, need to be financed and championed for scale-up, penetration and coverage. And we are hopeful that pre-exposure prophylaxis will contribute to the prevention arsenal in the near future.
Read the rest of this article on drug safety here.
Esther’s Story: Improving the odds in the struggle against TB, HIV/AIDS and Malaria
The African Medical and Research Foundation (AMREF) Malaria, HIV/AIDS and Tuberculosis (MAT) program works with healthcare staff in Luwero, Uganda, to sensitize local communities on health issues. AMREF provides training and transport to health center staff, and in some cases provides allowances for lunch while staff are in the field. Without this kind of support, healthcare staff members – like Ester Nakamya - are unable to do their work and reach people in their communities.
Read Ester’s story:
I have been working in Luwero as a health assistant since 2000. One day, in one of our usual staff meetings at Kasana Health Center in Luwero town, an organization called AMREF was introduced to the health workers present. We were told AMREF had come to support us to deliver better health services in our district. I could see the enthusiasm of the chairperson of the meeting, who urged us to work closely with and tap whatever benefit we could from AMREF. We badly needed health partners as the district was overstretched with health issues and yet the funding and other capacities to handle were still inadequate. I left the meeting wondering how I was to benefit from AMREF’s involvement as an individual, since I too had challenges in meeting my job expectations.
My role as a health assistant is to mobilize people and educate them about health issues, specifically tuberculosis (TB). I encourage patients to go for TB tests, and if one is diagnosed with TB, I am supposed to follow up with them to ensure that they take and complete the full course of medicine that was prescribed to them. I also visit TB patients; I counsel them, transport drugs to them, and sensitize community members on how to reduce the stigma related to the disease.
I was working in 57 villages , following up with patients and transporting drugs. The only transportation I could afford at that time was a bicycle, which sometimes meant that patients who were unable to pick up their drugs did not have them when they needed them. Also, without my coaching, some other patients would get tired of swallowing the big tablets twice a day for about 60 days and would miss taking them. Both of these scenarios pose challenges to recovery from the disease.
Read the rest of this story about access to medicine here.