Category: Trade and Health

Trade, Health, and Access to the COVID Vaccines

by ihsection, posted in APHA IH Section, Guest Blog, Trade and Health

By: Mary Anne Mercer, IH Section representative in the Trade and Health Forum

The International Health Section is part of the Trade and Health Forum, an intersectional group that aims to inform and activate members on how various aspects of trade affects health, both at home and in the rest of the world. That topic is a bit of a mystery to most of us. But as globalization becomes ever more evident, the relevance of its effects on health is more obvious.

Take the COVID-19 pandemic, for example.  If there is one key lesson to be learned from this past year, it’s that we will only be able to crush the pandemic here when it can be done everywhere. And an important strategy to making that happen is to step up access to the new vaccines as quickly and as widely as possible.  “Herd immunity” can only be reached safely by massive levels of immunizations.

 Right now the 84% of the world’s population that lives in low and middle-income countries is at a huge disadvantage because of rules of the World Trade Organization (WTO) constraining the development of generic drugs and vaccines. Those of us who were involved in the early response to AIDS in Africa see eerie parallels with that time. The first drugs to treat AIDS were too costly for low-income countries to adopt. I worked with a health program in Mozambique in the late 1990’s, and it was only after an Indian pharmaceutical company, CIPLA, began producing generic versions of the triple-drug therapy in 2001 that we were able to support drug treatment for people living with HIV and AIDS.  As a result of that delay of more than a dozen years—during which HIV spread unchecked in countries unable to afford drug treatment—some 15 million Africans died of AIDS. 

Right now global access to the vaccine is an important issue that is central to concerns of the Trade and Health group. The WTO patent regulations in question are documented as Trade-Related Intellectual Property right section (TRIPS). The WTO can temporarily waive the patents on COVID vaccines to allow generics to be developed—which would allow a massive scale-up of the immunization effort. The proposal to issue an emergency TRIPS waiver for the period of the pandemic has wide support in low and middle income countries but, so far, is opposed by the currently US administration as well as several other of the rich countries. 

The essence of the patent waiver controversy is, of course, the bottom line. Pharmaceutical profits tend to be substantial; it’s estimated that the profit margin for the Pfizer vaccine, for example, will be four billion dollars by the time the pandemic ends.  The US could be a leader in supporting the proposed TRIPS waiver, but so far has not indicated it’s willing to take that stand.

For more information about this issue, please check out my recent Medium article or any number of concerned groups such as Global Trade Watch and HealthGap.  And take action!

Future of Conflict Minerals murky under Trump administration

by Kendall Penndorf, posted in APHA IH Section, Human Rights, Policy and Advocacy, Trade and Health

You’ve likely heard the term “blood diamonds.”  Also known as “conflict diamonds,” these precious stones have helped fund civil wars and contributed to some 3.7 million deaths in Angola, Sierra Leone, and the Democratic Republic of Congo (DRC) according to an Amnesty International report.

The term “conflict minerals” doesn’t have quite the same ring, nor a titular film starring Leonardo DiCaprio, but they are at the center of a recently leaked memo from the White House.  The memo seeks to dismantle the Conflict Minerals Rule in the 2010 Dodd-Frank Wall Street Reform and Protection Act.  Under Dodd-Frank, companies had to disclose whether or not their products contain minerals mined in the Democratic Republic of Congo or a neighboring country.  The reason to withdraw this clause that valued human life over electronics?  Perceived job loss and costs to American companies, estimated at $3-4 billion in upfront compliance costs and $200 million annually thereafter.

What is life like for the miners of conflict minerals – tin, tantalum, tungsten, and gold ore – in the Democratic Republic of Congo and neighboring countries?  The Guardian reports a systematic web of sexual violence, kidnapping, child labor, and modern-day slavery.

An overwhelming abundance of human suffering all so we can play Bejeweled on an almost dizzying array of devices.  Tech giants, Apple and Intel, have spoken out against the repeal of the Conflict Minerals Rule, but fear that enforcement will be difficult without written law.  Human rights groups representing some 100 organizations in and around DRC have also spoken out against repeal of the Rule:

Thanks to the Dodd-Frank Act, Eastern DRC has to date more than 220 certified green mining sites, more than 300 mining police officers trained and deployed to secure mining sites,an independent audit mechanism, and a regional certification system. These advances undoubtedly contribute to reducing the rate of crime and human rights violations, including rape of women and exploitation of children in mining areas. All these efforts and progress will be destroyed if the US Government decides to contradict itself by repealing the Dodd-Frank Act.

It isn’t just Big Business that has taken a hit under the Conflict Minerals Rule.  A healthy dose of criticism cites that the Rule has actually made miners and their families in DRC poorer.  In many ways, the implementation of the Rule slowed down, or stopped, mining due to implementation issues of the government and business variety.  Millions, out of work, were left between the proverbial rock and the hard place: either face starvation or join the militias that the very Rule were designed to protect them against.  Closing of mines is felt throughout communities:

With less money flowing in, shops in Luntukulu have closed. Many people struggle to feed their families through farming. “If Obama’s law wasn’t signed, the ban would not have existed,” said Waso Mutiki, 41, president of the miners’ co-operative in Luntukulu. “It destroyed everything.”

Others who contest the Rule say that the it does not acknowledge or alleviate deeply systemic issues afflicting the region, such as in this open letter signed by academics, politicians, and civil society professionals:

First, while the minerals help perpetuate the conflict, they are not its cause. National and regional political struggles over power and influence as well as issues such as access to land and questions of citizenship and identity are just some of the more structural drivers of conflict. The ability to exploit and profit from minerals is often a means to finance military operations to address these issues, rather than an end in itself.

The authors of the open letter above offer some alternative strategies which seek to buoy the economy by incentivising better practice and fair competition for international and Congolese businesses. Dollar for dollar, the Democratic Republic of the Congo is one of the richest countries in the world when it comes to untapped mineral resources.  The people who seek to own that wealth and exploit its potential are many, and unfortunately, Congolese citizens and their communities are not among those to first reap those benefits.

So, what is the bottom line?   Some might say the Conflict Minerals Rule sees the forest but not the trees, doing significant damage to local economies and livelihoods despite the progress made by eliminating a driver of local conflict.  It serves as yet another example of the need for policies to be developed and refined with community feedback. A globally engaged U.S. administration might attempt to build on the successes of the Rule with foreign and trade policy that takes such feedback into account. But the current administration seems to have different priorities. Rather than approaching policymaking in a way that benefits the communities most heavily impacted, or even that takes into account the expectations of American consumers, President Trump fights for the common man…the average, American CEO:

Government and community collaboration are key in achieving meaningful reform. Whether or not the U.S. Administration will take part in that exchange remains to be seen.

A New Context for Development Effectiveness

by scanyatonwu, posted in Aid Effectiveness, APHA IH Section, Trade and Health

an-age-of-choice-for-development-finance_evidence-from-country-case-studies

For those of you interested in the past, present, and future of international aid and development, this blog post will provide you with an introduction to frameworks and partnerships that have evolved over the past few decades. It will also highlight an organization that caught my interest when I stumbled upon its “Aid in Danger: the Perils and Promise of Humanitarianism” series.

The Overseas Development Institute (ODI) is an independent think tank located in the United Kingdom (UK). For more than fifty years, the institute’s main focus has been on informing policy and practice that result in poverty reduction and sustainability in international development as well as humanitarian efforts. ODI hosted its 2016 Center for Aide and Public Expenditure (CAPE) conference from October 18th-19th, with the goal of updating the Global Partnership for Effective Development Co-operation’s development effectiveness agenda to reflect a new context that has emerged over the past 10 years. This context involves additional evidence that has been gathered on development effectiveness implementation, a commitment to the Sustainable Development Goals (SDGs), positive changes in donor-recipient relationships, and an increased number of finance providers. Although developing countries now have a broader selection of finance providers to assist them, including actors in the private sector, these new players may not be familiar with the Monterrey Consensus  or High Level Fora on Aid Effectiveness that were developed to cast vision and establish commitment to development co-operation and improvements in the quality of aid delivery. As a result, if these new finance providers do not adhere to or are not aware of key discussions that have taken place to improve overall aid and development initiatives, then it makes it difficult to evaluate their impact.

The Organisation for Economic Co-opertation and Development works with key players such as governments and multilateral organizations to “improve the quality of development co-operation.” Despite international development effectiveness and co-operation partnerships being greatly shaped by the High Level Fora on Aid Effectiveness, time and budget constraints, unattainable goals, and mixed political motivations have prevented lasting change from taking place. More specifically, traditional development effectiveness principles have been based on the Paris Declaration of Aid Effectiveness  and the Busan Partnership for Effective Development. The common set of principles previously defined as having contributed to improved quality of aid was reinforced by the Busan Partnership, which went a step further and developed the following action points for implementation:

  • Use results frameworks designed with the needs of the partner country in mind as a common tool, and using country-led coordination arrangements.
  • Untie aid to the maximum extent possible and – in 2012 – review plans to achieve this.
  • Use country public financial management systems as the default option for development financing, and support the strengthening of these systems where necessary.
  • Strengthen transparency and approve a common standard for the electronic publication of data on development co-operation, to be fully implemented by 2015
  • In 2012, establish common principles to prevent the proliferation of multilateral organisation and global programmes and funds, also in 2012 establish common principles to tackle the issue of countries that receive insufficient assistance (aid orphans).
  • By 2013, provide recipient countries with regular, timely, indicative three-to-five-year forward expenditure plans.
  • Increase support given to parliaments and local governments in carrying out their functions. Foster an environment for civil society organisations as independent development actors.

More recently, ODI research has shown that developing countries are more likely to pick and choose which effectiveness principles to implement and that there are priorities outside of effectiveness principles that also influence countries.

Overall, the conference focused on two main questions:
1) How does the private sector play a role in development and is it effective?
2) What is the role of external support as the SDGs focus on development for all people everywhere and policies that “leave no one behind?”

Stay tuned for more….

@MSF Video: Patents and the fight for #generics

by Kendall Penndorf, posted in APHA IH Section, News, Pharmaceuticals, Trade and Health

Intellectual property protects those items that we can’t live without – think Netflix and the iPhone 7 – and those that we would surely die without, including life saving and extending medications.  Today’s video covers the latter and the barriers much of the developed world faces courtesy of patent laws that protect pharmaceutical companies.  This issue has come to recent attention as the UN’s Panel on Access to Medicines published its recommendations to Big Pharma’s chagrin.

At the crux of the UN Recommendations is a struggle that pits profits against people.  Enacted in 1995 by the World Trade Organization, the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced minimum standards for protecting intellectual property, including patents on medicine.  TRIPS proved a boon for international trade, but set a 20-year patent on novel medication.  Only after the patent lapses can generic alternatives hit the marketplace.  It is at this point when many lifesaving and extending drugs are first available to the developing world.  The price tag of a medication to treat HIV/AIDS can drop from $10,000 per year to $200 due to generics.

Under TRIPS, each country has the right to a grant compulsory license, as stated in this excerpt:

Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(b)   such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

In layman’s terms, if it is in the public’s best interest, generic drugs can be pursued without the patent holder’s consent.

A few years after TRIPS, South Africa attempted to pass an act that would grant a compulsory license for antiretroviral therapy in response to a staggering HIV/AIDS epidemic. The act was met with a lawsuit by 40 multinational companies and the United States, citing South Africa in violation of the TRIPS agreement, though executed in the midst a public health crisis.  Despite controversy, President Nelson Mandela signed the act into law and the lawsuit was eventually dropped.  In response, the World Trade Organization signed the Doha Declaration in 2001 to further clarify the right to grant compulsory licenses.

Nearly 20 years after TRIPS and Doha, the developing world continues to suffer from catastrophic levels of health inequality.  Africa, among the hardest hit, is home to nearly half of all tuberculosis cases and 91% of HIV-positive children. Countries that attempt to circumvent TRIPS, even in the direst of public health crises, are subject to retaliation by termination of trade agreements that help keep their economies afloat.

Earlier this year, Colombian Health Minister Alejandro Gaviria, warned a large pharmaceutical company, Novartis, that a compulsory license to pursue a generic form of a popular cancer drug was imminent if Novartis didn’t lower its prices.  In a letter from the Colombian Embassy in Washington, Colombia’s government was threatened by the United States with withdrawal of support to join the Trans-Pacific Partnership trade zone and funding to facilitate a peace deal with a longstanding rebel group.

The exorbitant cost of pharmaceuticals can also threaten consumers in developed countries.  Recent outcry over the soaring price of the anaphylaxis drug, EpiPen, has many in the United States worried. The price of EpiPen has gone from $60 to over $600 in recent years and are now exclusively sold in two-packs, further increasing the cost for consumers.  A similar product, Adrenaclick, is not considered equally therapeutic to EpiPen and pharmacies are unable to fill prescriptions.  Another pharmaceutical company applied to make a generic version, but the application was rejected by the FDA.

This has led to repercussions such as children carrying expired EpiPens and EMTs dispensing epinephrine by syringe, which makes it much harder to administer the correct dose.  A recent article in the American Journal of Medicine suggests that EpiPens be added to a list of preventive medicines, effectively lowering the copay without lowering the overall price of the drug by the pharmaceutical company, Mylan Specialty.  The cost would likely be shifted to consumers in higher deductibles.

In light of the UN recommendations, what is the next step to guarantee medications are available to those who need them?  Dr. Bernard Pecoul of Drugs for Neglected Diseases Initiative urges action, not apathy:

“Governments mustn’t allow the report to become yet another exercise that describes the current failures of the medical innovation system without contributing concrete steps to address those failures. Responsibility now clearly falls on them at the highest political levels to act by putting in place innovative and practical solutions.”


Big losses for Big Tobacco

by ihsection, posted in Trade and Health

By Abbhirami Rajagopal

Six million people die annually as a result of tobacco. Many governments have adopted the WHO framework for tobacco control and have since taken measures (policy changes, cessation programs, etc.) to reduce mortalities and morbidities that occur due to tobacco. Not surprisingly, big tobacco companies like Philip Morris International have pushed back against countries that have enacted stringent packaging laws.

In a much-awaited decision, Australia won an international legal battle to uphold its tobacco policies that include the plain packaging laws. Australia has enacted some of the toughest measures to reduce the harm caused by tobacco and plain packaging laws are among them. These laws are intended to prevent the tobacco companies from displaying their distinctive designs, colors or even their brand logos (companies can include their names and logos, but they cannot have flashy, enticing packaging). Instead, the companies would be required to use olive-green packs with health warnings and graphic color images that would cover nearly 75% of the front of the packs. The Plain Packaging Act passed by the Australian parliament became law in 2011 and, shortly thereafter, Hong Kong-based PMI sought legal action against Australia citing that, by stripping logos off the packs, these stringent laws violated the bilateral investment treaty between Australia and Hong Kong, thereby severely diminishing their brand value.

This is not the first time Philip Morris has dragged governments into legal battles over stricter anti-smoking and tobacco laws.

While global rate of lung cancer mortality was increasing between 1990 and 2013, owing to stricter anti-tobacco measures, Uruguay saw a 15% reduction in lung cancer mortality. PMI, a company whose revenues were nearly $80 billion in 2013, sued Uruguay, a small country of 3 million with a GDP of about $56 billion, in 2013. The lawsuit was brought to the International Center for Settlement of Investment Disputes (ICSID) in 2010 and the company is seeking $25 million in damages from Uruguay, once again, citing violation of bilateral investment treaty between Uruguay and Switzerland. The ICSID is expected to settle this case by arbitration.

The upholding of the anti-tobacco laws in Australia will hopefully set a precedent and allow countries to move forward with legitimate public health actions to curb the global tobacco epidemic without interference from tobacco companies.