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Protecting Free Speech in Medicine

Christina Sandefur March 29, 2017
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Under federal law, pharmaceutical companies can be charged with a crime simply for telling a doctor about a legal, alternative use for an approved treatment. Sadly, government routinely censors the communication of valuable and truthful information that could help improve – and even save – people’s lives.

This changed in Arizona last week when Governor Doug Ducey signed HB 2382, a new state law that safeguards the free speech rights of those in the medical field to share truthful research and information about alternative uses for FDA-approved medicines. [Read More]

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Is IRS sharing confidential taxpayer information with HHS to promote Obamacare?

Eileen J. O'Connor September 26, 2016
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Yet another ugly aspect of the “Affordable Care Act” has come to light. People who read the legislative language understood at the outset that the if you like your doctor, you can keep your doctor; if you like your plan, you can keep your plan promise was a lie.  Others found out the hard way, when their health insurance policies were cancelled, and their doctors turned them away. Anyone with a rudimentary grasp of how markets work could have predicted that, notwithstanding promises to the contrary, service would suffer and costs would rise, as they have. 

Now we see another ugly consequence of the ACA: the Internal Revenue Service is using confidential information taxpayers provide on tax returns to identify people who chose to pay the Obamacare penalty rather than enroll in an exchange or otherwise buy health insurance. IRS then provides the identities and contact information of these opt-outs to Centers for Medicare and Medicaid Services, which uses the information for “marketing outreach” (harassment?) to encourage (pressure?) these people to enroll in the government-mandated healthcare insurance coverage.  House Majority Leader Kevin McCarthy, Majority Whip Steve Scalise, and Ways and Means Committee Chairman Kevin Brady have written to IRS Commissioner Koskinen objecting to this violation of taxpayer privacy, and asking questions about it. 

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United Nations' final report on medicine access deeply flawed

Marisa Maleck September 22, 2016
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On September 14, the United Nations’ High Level Panel on Access to Medicines released its long-anticipated final report, which purports to provide recommendations for improving global access to health care. Amidst murmurings that the Panel was poised to focus on intellectual-property rights, experts urged the group to consider real barriers to access such as weak infrastructure and a dearth of skilled healthcare workers. But the Panel chose not to heed their advice. Although the Panel acknowledged numerous factors that stop people from getting the life-saving medicines they need, it explained that it had a narrow mandate to focus on a perceived incoherence between intellectual-property rights and access to health care.  [Read More]

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The United Nations’ Misguided Approach to Healthcare Access

Marisa Maleck September 06, 2016
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Intellectual property (IP) protections promote innovation and spur research and development into life-saving drugs and medical procedures. Indeed, the existence of robust systems of IP rights in Western industrialized nations is one reason the pharmaceutical industry and medical breakthroughs have flourished there. By contrast, drug companies have struggled in the developing world, where IP protections are either nascent or non-existent.

One would think, therefore, that global policy advocates would encourage strong, uniform IP protections to help ensure the continued development of innovate treatments and broader access to health care in emerging markets. But instead of pursuing this sensible course, an obscure United Nations (UN) body called the High Level Panel on Access to Medicines is poised to release a report that is likely to recommend scaling back IP rights worldwide. This would be a tragedy for millions of ailing patients around the world.

There is no doubt that a substantial need exists to improve access to medicines to the developing world. Approximately one in three patients in the developing world lack access to basic treatments. To solve this problem, the UN must focus on substantial barriers to access such as a lack of infrastructure and training. Yet the panel appears ready to ignore these barriers by myopically and mistakenly focusing on IP rights.

Established last year by UN Secretary General Ban Ki-moon to improve global access to life-saving medications, the Panel was tasked with a mandate “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” Consistent with this charter, the sixteen-member Panel has reviewed proposals to address what it perceives to be a “misalignment” between inventors’ rights and “access to medicines, vaccines, diagnostics and health technologies.” The Panel is currently finalizing a report to the Secretary-General, which includes an analysis of the proposals and its recommendations. The Secretary-General, in turn, plans to make the report available to the General Assembly, and undertake unspecified further action.

Many leaks from the group’s proceedings confirm its plan to emphasize perceived problems with IP rights rather than consider other issues that might hinder access to medicine. The rumors became so pervasive that, in June of this year, the Panel issued an “Official Statement on Speculative Media Reports.” The statement merely avers that the Panel is still working on the report, but it does not in any way deny that the group’s focus is on what it perceives to be a disconnect between access to healthcare and IP rights.

The U.S. State Department has encouraged the Panel to shift its narrow focus on IP rights to tackle the real structural and economic problems that prevent access to health care in the developing world. The Panel should heed the State Department’s advice for one simple reason: There is no “policy incoherence” or “misalignment” between IP rights and access to health care.

For starters, the vast majority of medicines that have been designated as essential by the World Health Organization (WHO)—350 of 375—are not even under patents. Rather, these medicines are currently available in relatively inexpensive generic varieties.

In addition, many life-changing breakthroughs in drug research and development are made possible only because of America’s (and other countries’) extensive protections for IP. These protections grant companies a period of market exclusivity for original products, providing an incentive for companies and their investors to invest billions in research and development of the next generation of medications. Indeed, where countries have recently adopted more robust IP protections—such as India and China—pharmaceutical development and partnerships with Western drug companies have flourished and improved access to medicine. Furthermore, strong IP protections reduce the incentives for companies to develop fake or counterfeit drugs, thus helping to ensure quality control in the developing world.

Ultimately, the Panel’s mandate to root out policy incoherence between IP rights and health care begs the critical question—do IP rights promote or hinder access to drugs and medical treatments in the developing world? The empirical evidence shows that IP rights improve access to health care in poorer countries. Therefore, the Panel should reconsider its marching orders and release a report that focuses on addressing the political, economic, and structural barriers to medicine in the developing world, rather than punishing companies that are responsible for putting life-saving products on the market. [Read More]