Drug price controls may shorten lives - report

Posted on December 18, 2008 by Patients and Patents

Imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows.

A Reuters article continues:

“We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime,” said Darius Lakdawalla of the nonprofit Rand Corporation, who worked on two studies appearing in a special report on drug pricing in the journal Health Affairs.

“But in many other cases, those policies resulted in very substantial losses to consumers in the form of reduced life expectancy and those would be worth tens of thousands of dollars,” Lakdawalla said in a telephone interview.

Some policymakers have suggested the United States adopt some form of price regulation as a way to curb rising prescription drug costs. Most European countries regulate drug costs, which is one reason European nations spend less than two-thirds as much per person on drugs each year than the United States.

Lakdawalla and colleagues used computer models of price regulation in 19 countries to simulate the impact of price controls that cut drug company revenues by 20 percent.

They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.

“We found longevity declines on the order of about a half of year for people at the age of 55 when you look out to people who are alive in 2050 and 2060,” he said.

Lakdawalla said a better approach would be to cut drug insurance co-payments by 20 percent, which would increase life expectancy in the United States by a half year by 2060 as more people take needed drugs and higher drug profits stimulate innovation.

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Counterfeit Drugs: Definitions Matter, but Not as Much as Quality and Safety

Posted on December 15, 2008 by kmlybecker

 Dr. Kristina M. Lybecker

The safety and efficacy of medicines is something that most patients in developed countries take for granted.  Whether it’s a vaccination, prescription, or over the counter drug, most people assume that the medicines they’re getting are legitimate.  While bogus drugs are most frequently found in the most vulnerable markets – those of developing nations that all too often lack access to medicines –  this is certainly not always the case. 

Over the past year, many developed countries have placed a greater focus on ensuring the safety of the drug supply chain.  Brought to the fore by the deaths of a number of patients in the United States who received a counterfeit batch of the blood thinner heparin in early 2007, drug regulators in North America and Europe in particular have been placing a greater focus on ensuring the safety of the drug supply chain.  One of the great challenges facing regulators is the global scope of drug production and distribution.  No single country can effectively address this problem.

According to the US-based Centre for Medicines in the Public Interest (CMPI), counterfeit drug commerce is estimated to grow 13% annually through 2010.  “That means counterfeit drug sales will grow at nearly twice the rate of legitimate pharmaceutical commerce,” states Peter Pitts, President of CMPI.  “In 2010 this illegal business will generate $75 billion in revenues – a 92% increase from 2005.  The profits are high and the risks are low.  That’s a deadly combination.”

Earlier this year, a draft resolution on counterfeit medical products was submitted to the World Health Assembly by the nations of Gambia, Ghana, Nigeria, Tunisia and the United Arab Emirates.  Their efforts clearly bring a critical public health challenge to the WHA agenda, and yet special interest groups have side-tracked this initiative into a great debate over the definition of ‘counterfeit’. 

This is not to suggest that definitions don’t matter.  Certainly they do.  But those who are quibbling over words seem to have lost track of the bigger picture:  quality medicines and safe drugs.  Implicit in all efforts to eliminate counterfeiting is the recognition that drugs should be safe and consumers should have accurate information about their pharmaceutical choices.

Counterfeit and substandard drugs are dangerous not only to the patients who take them, but to the global community as a whole through the drug resistance that they propagate.  Antimalarial drugs are an unfortunate example of this situation.  In a recent article published by PLoS One, antimalarial drugs from the major cities of six African nations were purchased and chemically analyzed.  Thirty five percent of all samples failed to register active pharmaceutical ingredient content against internationally acceptable standards.  The case of malaria is particularly troubling given the limited therapies available.  As described in the article, the drug resistance fostered by substandard products “places the future of malaria treatment at risk globally”.  

Delegates at the 61st World Health Assembly spent much of their time discussing the recommendations of an Intergovernmental Working Group on ways to encourage research and development for neglected diseases and improve access to medicines for developing nations.   Unfortunately, the issue of counterfeit medicines was not considered in these discussions.

If the World Health Organization and the global community are serious about improving access to medicines, they must aggressively tackle combating counterfeit drugs.  It is essential to move beyond fine tuning definitions to establishing an effective, global anti-counterfeiting strategy.   Ensuring quality in pharmaceutical manufacturing begins with the ingredients or APIs (active pharmaceutical ingredients) and must be safeguarded through to final products.   Effective oversight and a secure pharmaceutical supply chain will help to protect consumers from counterfeits as well as substandard production.

The United States, European Union and Australia recently announced a joint venture to improve the inspection processes of pharmaceutical manufacturing facilities around the world.  While this is an encouraging start, a more comprehensive effort is required to truly improve global health and to eliminate all barriers to access, including counterfeits.  

Lybecker is an Assistant Professor in the Department of Economics and Business at Colorado College.  She has consulted for the US FDA, Reconnaissance International, the World Bank, PhRMA, as well as several multinational pharmaceutical firms on the issues of pharmaceutical counterfeiting, access to medicines, corruption, and innovation.

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A Nigerian perspective on access barriers to medicines and treatment

Posted on December 4, 2008 by Patients and Patents

What are the real access barriers to healthcare for people in Sub-Saharan Africa?  The following article from the Wall Street Journal Europe provides an interesting perspective on the healthcare challenges in Nigeria, with a focus on AIDS patients.  Mr. Ayodele states that the “real causes of restricted access to to AIDS drugs are Africa’s derelict transportation systems, widespread corruption and poor utility infrastructure.”

Moreover, he cautions that counterfeit and low-quality drugs are a serious threat — as they not only don’t provide patients with effective treatment, but may also speed drug resistance.

Dangerous AIDS Policy
Drug patents are not the problem.

By THOMPSON AYODELE | LAGOS, Nigeria
November 30, 2008

Today, as we mark World AIDS Day, we should take stock of the suffering this disease continues to inflict, particularly in developing countries.

Twenty-five years after the disease was first discovered, AIDS continues to claim around two million lives each year. As an African, I’ve witnessed the suffering first-hand. My home region of sub-Saharan Africa has 12% of the world’s population, but accounts for two-thirds of those infected with AIDS and 75% of all AIDS-related deaths.

Western activists continue to blame the high price of drugs for the disease’s continued prevalence in Africa. They argue that poor countries should be permitted to break pharmaceutical patents to produce cheap knock-off versions at home.

Unfortunately, the activists are not just wrong; their policy proposal is flat-out dangerous. The real causes of restricted access to AIDS drugs are Africa’s derelict transportation systems, widespread corruption and poor utility infrastructure.

Most of the high-quality AIDS drugs that Africa imports have to be transported over vast distances and stored for extended periods of time before they can be distributed. But the roads and warehouses in most African countries are poorly maintained. Electricity, needed to keep drugs refrigerated, is scarce. Corrupt officials often exploit weaknesses in the supply chain, and extort hefty bribes from aid personnel.

In 2001, African leaders pledged to invest 15% of their budgets in health-care infrastructure. Seven years later, very few have come even close to meeting that commitment. Nigeria, for example, devotes less than 6% of its budget to health. Most of Africa’s impoverished people still lack health insurance. Medical workers earn low wages, which has led to low morale and a dearth of qualified personnel. The National Association of Nigerian Nurses and Midwifes says the country’s hospitals urgently need 300,000 additional nurses.

The trade policies of African governments often make the AIDS problem worse. Generic drugs imported into Kenya, Uganda and Tanzania are subject to a 10% tariff. The rate jumps to 40% in Sierra Leone, and to 50% in Kenya. Nigeria charges an import tariff of up to 39%.

Giving African governments the power to locally manufacture patent-protected pharmaceuticals will likely result in patients receiving low-quality drugs. In Thailand and India, for example, locally produced Aids drugs are often of such low quality that they’re actually fueling drug resistance.

Western drug companies have already gone to great lengths to make their drugs affordable to the world’s poorest patients. Many use tiered pricing models, in which Western customers pay substantially higher prices than people in poor countries. And just last year, GlaxoSmithKline, Merck and Pfizer donated hundreds of millions of dollars worth of drugs to Africa.

On World AIDS Day, it’s important to look at how the West can better assist the developing world in its battle against this deadly disease. But we cannot forget that local governments need to play their part as well. Instead of meddling with patent protections, without which there would be no drug innovation, they need to clean up their policies.

Mr. Ayodele is executive director of Initiative for Public Policy Analysis.

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New National Intellectual Property Strategy for Barbados

Posted on November 21, 2008 by Patients and Patents

Experts from the public and private sectors participated yesterday in a National Consultation on the Formulation of a National Intellectual Property Strategy for Barbados, hosted by the Ministry of Foreign Trade and International Business.

Donville Inniss, the Minister of State in the Ministry of International Business said the strategy would assist in realizing the full potential of intellectual property in Barbados and the benefits that can be derived.

There can be no doubt that without a national intellectual property strategy, a country will experience many challenges in encouraging, promoting and protecting indigenous creativity and innovation.

The Consultation highlighted intellectual property strategies and key recommendations from intensive working group sessions.  The meeting was designed to stimulate public awareness of the various aspects of intellectual property and show how such valuable assets can be developed and managed efficiently to enhance the social and economic advancement of Barbados.

References:
Nation News
Caribbean Press Releases

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Members of WHO Expert Working Group on R&D Financing announced

Posted on November 20, 2008 by Patients and Patents

IP Watch reports that the World Health Organization has released a long-awaited list of high-level experts tasked with finding innovative funding mechanisms for needed medical research on neglected diseases. The list largely contains governmental and intergovernmental representatives.  The list of Expert Working Group members is available from the WHO website.

This group will examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases.

The group includes representatives from developed and developing nation governments, international organisations, think tanks and academia. The group is expected to report to the WHO Executive Board meeting in January 2009.

Some initial commentary on the Working Group includes:

  • A developed country official said it is “a pretty good group” and “I look forward to following their work.”
  • Richard Kjeldgaard, associate vice president for international intellectual property at the Pharmaceutical Research and Manufacturers of America, said the group looks “forward to working with the expert group as they examine proposals for new and innovative funding sources” aimed at addressing developing country needs. 
  • Sisule Musungu, president of think tank IQsensato, cautioned that high credentials alone “will not resolve the question, since the problem requires interdisciplinary analysis… and thinking ‘outside the box.’” The group’s “willingness to learn” and to “listen to a variety of ideas” will be critical, he added.

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Strong IP system boosts knowledge economy development

Posted on November 17, 2008 by Patients and Patents

Strong intellectual property protection is essential to the economic growth of developing countries, according to a senior official with the World Intellectual Property Association.   “It is a myth and complete misunderstanding to think that IP protection is not important. It is relevant to all countries wanting to build up their economy,” stated the WIPO official.

Ensuring strong intellectual property protection also encourages innovation, which is particularly important as it relates to medical innovation.  Patients around the world benefit from the development of new medical treatments as well as improvements to existing technologies, products and processes.

Malaysian National News Service - Strong IP System To Boost Knowledge Economy Development
GENEVA, Nov 14 (Bernama) — A strong intellectual property (IP) system not only boosts but forms an essential component of a countrys development of its knowledge-based economy, says a senior official with the World Intellectual Property Organisation (WIPO).

“It is a myth and complete misunderstanding to think that IP protection is not important. It is relevant to all countries wanting to build up their economy,” said Yo Takagi, an executive director with WIPO.

Today’s economic growth is being led by innovation where it has surpassed labour and productivity growth in some countries, he said.

“Knowledge-based international trade in the recent decades has increased and on a global average it has overtaken the trade of resource-based products,” Takagi said during a seminar on IP here for journalists from 25 developing countries and countries in transition.

In the share of exports comprising manufactured products globally by technology, in the last 30 years, middle-tech products have remained in the upper rung, while high-tech products have begun to surpass that of lower tech products and resource-based products, he said.

There is no denying that innovation in all areas has become the driving force of economic growth and with this, the increasing importance of properly placed IP laws which will protect the owners of such properties and rightfully the economic benefits that they will be able to derive from their innovations, Takagi said.

“Twenty-eight years ago, IP was covered by dust, nobody thought of it as an important aspect of economic development. A good IP system will both nurture the growth of intellectual properties and their protection against various infringements,” he said.

An IP is broadly described as an authentic creation, big or small, whether of a complete product or part of product, a technology as well as creative works like designs and writing, and it can be the creation of a company or an individual. It gives the creator of the entity the right to protect the work or entity lawfully, whether through the ownership of a patent, copyright and trademark.

All intellectual properties are economic tools and as such they should be rightfully protected and respected. But in reality, it is not always so.

While there are various international and national laws governing patents, copyrights and trademark, the infringements are wide and many, often going across borders.

The infringements are plenty and the area of IP has remained a major challenge for policy makers as well as legal practitioners in the field amid the growing challenges and technologies thrown in by the new media like the Internet.

Among others, education, establishing national systems of innovation, IP institutions are all factors that will contribute towards using IP as a tool for development and will also enhance a nation’s competitiveness when participating in the global market, Takagi said.

Malaysia has been one of the earliest countries in the Asian region to sign on a WIPO treaty. In 2007, it was among the top 10 developing countries filing for patents with the WIPO.

The origin of WIPO dates back to the late 19th century with the adoption of the first international IP treaty, the Paris Convention for the protection of industrial properties. Today, it is one of the 16 specialised agencies of the United Nations.

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Director of PAHO blogs about annual meeting, public health and innovation

Posted on November 13, 2008 by Patients and Patents

The Director of the Pan-American Health Organization (Mirta Roses) stated in her blog that this year’s PAHO assembly would focus particularly on matters related to innovation and research.  ”Proposals for action to strengthen vital and health statistics, as well as the link between public health, innovation, and intellectual property, are part of our integral efforts to promote evidence-based policies.”

The debate around ensuring access to safe medicines and protecting strong incentives for continued medical innovation is of the utmost importance to patients around the world.  It is unfortunate that, more than a month after the annual meeting, PAHO seems to be maintaining the same secrecy as did the World Health Organization in the development of their Intergovernmental Working Group on Public Health, Innovation and Intellectual Property.  As PAHO further explores these issues, it is essential that patients be included in the process.

Director of PAHO’s Blog
The Home for Health in the Americas strengthening actions in public health and improving the social protection in health for our populations.

This week we are celebrating at our Headquarters, which I also call the Home for Health in the Americas, the 48th Directing Council of our Organization, in which all the Member States participate. At the opening session, we had the good fortune to have with us Dr. Margaret Chan, Director-General of the World Health Organization, His Excellency José Miguel Insulza, Secretary-General of the Organization of American States, and representatives from the other institutions of the Inter-American system, the observer states, and agencies and entities that cooperate with our efforts.

The Council’s intense agenda, which will occupy the entire week, will focus particularly on matters related to innovation and research. Proposals for action to strengthen vital and health statistics, as well as the link between public health, innovation, and intellectual property, are part of our integral efforts to promote evidence-based policies.

We are taking this action because our commitment, each of us in his own area but conscious that all of us are connected to one another in a network to improve public health, is to get results. This demands self-criticism to examine the progress made toward meeting noble and ambitious targets, such as those in the Development Goals of the Millennium Declaration, and timely action to adopt the measures necessary for meeting them, such as the Regional Strategy and Plan of Action for Neonatal Health within the Continuum of Maternal, Neonatal, and Child Care. It also demands solidarity among the Member States, a distinctive feature of public health in our Region, exemplified once again in the recent launch of the Action NOW for the Lives of Mothers, Newborns, and Children Initiative, a notable example of horizontal cooperation and solidarity among developing countries that is supported by the Prime Minister of Norway and a network of political leaders, headed in our Region by President Bachelet and President Lula. I congratulate Dr. Chan on the success of her activities in this area in New York last week, and I thank all the many government authorities and First Ladies of the Region, who have made the improvement of maternal, neonatal, and child care a high political priority.

Solidarity also implies a resolute struggle against inequity and poverty and their terrible consequences for public health. For this reason, activities to promote social protection and equitable access to quality health services are moving forward. Examples of these are proposals to make progress in the elimination of neglected diseases and in staunch promotion of the primary health care strategy, as well as support for the priority countries, with special emphasis on collaborative health efforts in Haiti.

It is clear that measures to reduce the risk and burden of disease, among them the Regional Strategy and Plan of Action for Cervical Cancer Prevention and Control and efforts for the prevention and management of diabetes and obesity, should be viewed in the context of health determinants and actions to address them. Therefore, the agenda also includes climate change and its impact on public health, a phenomenon that has been the focus of much of our effort this year (to which I have referred in other blogs) and that, as the latest evidence reported some days ago reveals, is intensifying at a rate that exceeds even the grimmest scientific forecasts. The consequences are, unfortunately, very real. Some Ministers of Health, understandably, could not participate in the meeting because they are grappling with the consequences of the severe hurricane season in the Caribbean.

We have major challenges ahead of us, then, as well as opportunities that the participants in this meeting of the Directing Council will address with the sense of responsibility and commitment characteristic of people devoted to the mission of public health. I am certain that this week of working together in solidarity will lead to new successes in public health in the Region.

Mirta Roses

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Cancer, cardiovascular and other Type 1 diseases will cause over three quarters of all deaths by 2030

Posted on November 10, 2008 by Steven Lott

Drug Policy Monitor Newsletter
October 29, 2008

The global burden of disease is shifting from infectious diseases to non-communicable diseases, according to a recent report from the World Health Organization [1].  As populations age in middle- and low-income countries over the next 25 years, the proportion of deaths due to non-communicable diseases will rise significantly.  This trend will be accompanied by large declines in mortality from the main infectious diseases, including HIV, diarrhea, tuberculosis and malaria.

GLOBAL MORTALITY:  A SELECT COMPARISON OF LEADING CAUSES OF DEATH (2004-2030)
dpm-who-global-health-statistics
“In more and more countries the chief causes of death are non-communicable diseases, such as heart disease and stroke,” according to Dr Ties Boerma, Director of the WHO Department of Health Statistics and Informatics.

The decline in mortality due to infectious diseases is in large part due to research into these diseases, the development of new treatments by innovative pharmaceutical companies, improved disease prevention strategies (ie. mosquito nets), and a greater global commitment to improve health outcomes in developing countries.

Globally, deaths from cancer will increase from 7.4 million in 2004 to 11.8 million in 2030, and deaths from cardiovascular diseases will rise from 17.1 million to 23.4 million in the same period. Although deaths due to HIV/AIDS are projected to fall by 2030, it will remain the tenth leading cause of death worldwide.  Deaths due to other communicable diseases are projected to decline at a faster rate.

[1]  World Health Statistics 2008, World Health Organization, http://www.who.int/whosis/whostat/2008/en/index.html

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Biotech Innovation and the role of Intellectual Property

Posted on November 3, 2008 by Patients and Patents

Not surprisingly, the recent crisis in global financial markets has been front page news for the past few weeks.  The Wall Street Journal and other major publications have noted that the impact of this crisis goes well beyond the stock market. 

The Convergence Law Institute posted a number of comments in their blog about the impact of the crisis on the health industry, with a specific focus on biotechnology and innovation:

Biotech Distress
The Wall Street Journal headlines: “Cash Poor Biotech Firms Cut Research, Seek Aid,” adding that this “is threatening to slow the development of new medicines and cut high-tech jobs in the U.S. and Europe.”

Well, one approach to this problem would be to increase intellectual property rights in the biotech firm’s creations, as recommended in Saving the Goose: Intellectual Property and Follow-On Biologics (Sept. 17, 2008).

A problem with the current emphasis on allowing rapid entry of generics is that we will wind up with a system in which generic copycat drugs would be cheap — if only there were any original inventions to copy. Consumers’ pre-eminent interest is that new drugs be created in the first place.

More Biotech
The International Herald Tribune also says “Broader financial turmoil threatens biotech’s innovation”:

But this crisis comes as other factors were already souring investors on biotechnology. Drug development has become longer and more costly, in part because the Food and Drug Administration has become more demanding. And there is more pressure to cut drug prices.

So far this year, public and private biotechnology companies have raised $5.6 billion . . . .  That is only one-third the amount in all of 2007 and likely to be the lowest amount since 2002.

As noted yesterday, it is cold comfort to a patient to contemplate on how cheap a drug would be if only it existed when the non-existence is due to ideologues’ insistence that the price be set too low to justify investment in development.

One definition of an ideologue is someone who thinks it fine that others suffer to maintain the purity of his abstractions about how things ought to be.

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NAFDAC blacklists 22 Indian pharmaceutical firms

Posted on October 23, 2008 by Patients and Patents

According to the World Health Organization, counterfeit and sub-standard medicines represent an enormous public health challenge.  These products can range from random mixtures of harmful toxic substances to inactive, useless preparations.  Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest.  Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit.

The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has recently taken action to help ensure that the public has access to safe medicines.

NAFDAC blacklists 22 Indian pharmaceutical firms   
Vanguard (Nigeria)
Written by Chinyere Amalu    
Wednesday, 22 October 2008
 
THE National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted and banned 22 Indian pharmaceutical companies from exportation, importation and distribution of drugs in Nigeria.

The agency has also banned 40 drugs that are in circulation in Nigeria from being used, saying the names on the labels are fake and the agency cannot guarantee their safety and efficacy.

Announcing this yesterday in Abuja when the UNICEF Country Representative Suomi Sakai visited her, the Director-General of NAFDAC, Professor Dora Akunyili, said in 2003, the agency banned some Chinese pharmaceutical companies.

Some of the affected Indian companies are Medicare Pharma Ltd, O’Nell Pharma and Healthcare Ltd, Food and Pharma Ltd, Sep Pharmacy Ltd, Nexus Pharma Ltd, M/S Sanchuks Global Associates Ltd, M/S Tmoore Int’l Co. Nig. Ltd, Empree Medicament (1) Pvt among others.

Among the 40 Drugs that have also been banned from being used in the country are; MD-Artesunate Tablets, Artecare tablets, Careluther injection, Amoxmentin tablets, Erican-MG Cream, Vagitab, MD-Artesunate Syrup etc.

According to Akunyili who commended UNICEF for making breast-feeding initiative successful in Nigeria, the blacklisted companies and banned drugs takes immediate effect.

“NAFDAC hereby informs the general public that the underlisted Indian pharmaceutical companies have been blacklisted from the exportation, importation and distribution of drugs in Nigeria.

“We have also discovered that the 40 drugs that have been banned from being used in the country are fake. We noticed that the NAFDAC numbers on the labels are fake. What they do is to copy other companyies’ numbers.

“The agency is therefore warning the public not to buy or consume any of these drugs, irrespective of the manufacturer’s name on the label because NAFDAC cannot guarantee their safety and efficacy”, she stated.

Professor Akunyili, however, noted that the success Nigeria has recorded in its breast-feeding initiatives was as a result of UNICEF Baby friendly initiative.

“Today as the result of the initiative, anti-baby dirrhoea drugs have disappeared from pharmaceutical stores in Nigeria”, she added.

Earlier in her remarks, the Country Representative of UNICE, Suomi Sakai said her visit is to seek way of improving the existing partnership with UNICEF and NAFDAC.

According to her, we want to ensure that every Nigerian child gets products that are essential for their growth and development.

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