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U. N. Panel Threatens Pharmaceutical Innovation

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September 24, 2016 | 536 views | Post a comment

By Paul R. Michel

In America and across the globe, about 7,000 new medicines are in development. There’s no question that many of them will save lives. Unfortunately, the United Nations is working to degrade the innovation ecosystem that makes such breakthroughs possible.

In 2015, UN officials convened a new panel to study ways to improve impoverished countries' access to lifesaving medicines. By all indications, that panel will soon push to weaken intellectual property protections on medicines.

That would be a huge mistake. Such a policy shift would surely slow and possibly stop creation of new diagnostic tests and drugs, depriving patients of treatments like immune therapies and gene editing -- the biggest medical breakthroughs in a century.

The UN's High Level Panel on Access to Medicines, created by outgoing Secretary General Ban Ki-Moon, is comprised of public health experts, activists, and policymakers. Its charge: "Remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health."

Reworking policy to improve global public health is a laudable goal. Many patients in the developing world don't have access to needed medications. But there isn't any "incoherence" between the "justifiable rights of inventors" and "public health." Rather, IP rights incentivize the necessary but costly investment in research and development.

America has the most innovation-friendly legal regime in the world. Entrepreneurs and investors have been properly encouraged to create world-changing products and services. As a result, America is the global leader in drug innovation. In recent years, more than half of the new medicines introduced to market originated within our shores.

The economic benefits of IP protection also have been profound. American IP-based companies employ more than 40 million workers and account for $5 trillion of our gross domestic product -- over one-third of the U.S. economy.

Degrading IP protections would immediately impede drug research. Today, it takes on average more than $2 billion and over a decade of research and development to shepherd a new medication through the approval process. Of the medications approved for marketing, just 2 in 10 make up their development costs and turn a profit.

If the UN weakens IP rights, it would be even more difficult for innovators to see a return on their work. Investment in new research lines would collapse. As a result, patients will miss out on the next generation of vital medicines, for they would never be created.

Improving drug access in the developing world is a worthy cause. But IP rights are not the main obstacle. Rather, poor countries lack the physical infrastructure required to store and distribute medicines.

Vaccines, for instance, must be kept at a temperature between two and eight degrees Celsius. Tragically, many developing countries lack temperature-controlled storage equipment. For example, in tropical East Timor, researchers found medicines stored unprotected in warehouses that lacked air conditioning.

The High-Level Panel's charge seems biased against drug developers. A proper study would broadly ask what's really blocking access to medications and vaccines in developing countries. Most drugs are no longer even covered by patents, but are available as inexpensive generics.

If the panel fixates on undermining intellectual property rights, its work is all but certain to do more harm than good to global public health. Clearly the panel needs to re-think its mandate prior to the release of any report to the UN.

Paul R. Michel served on the United States Court of Appeals for the Federal Circuit for 22 years, and as its chief judge from 2004 until his retirement in 2010.
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