Baltimore Sun

Internatio­nal patent rights key to ensuring access to medication

- By Robert Freeman Robert A. Freeman is a professor of pharmacy administra­tion at the University of Maryland Eastern Shore. His email is rafreeman@umes.edu.

AUnited Nations panel recently released a series of disastrous policy recommenda­tions designed to increase access to medicines in developing countries. The panel ignored obvious solutions to help the one in three people in developing nations who lack regular access to medicines.

Secretary General Ban Ki-Moon originally tasked the UN High-Level Panel on Access to Medicines with remedying the “policy incoherenc­e” that exists between intellectu­al property rights and drug access. With that focus in mind, the panel predictabl­y — and wrongly — viewed IP protection­s as a barrier to access, rather than a bridge to medical innovation.

Underminin­g IP rights will not help patients in developing countries access medicines.

A 2016 Foreign Affairs study sought to determine whether strong patent protection­s increase the prices of drugs to developing countries. It examined prescripti­on drug expenditur­es over a decade in 17 countries with strict IP protection­s and compared them to a set of countries that did not have strong rules in place. It found that patents were not key drivers of higher expenditur­es.

Other studies have shown that patent protection­s, in fact, play a central role in ensuring that developing countries have access to medication­s.

An analysis of 68 countries over the period 1982-2002 found that patent protection­s, on both products and processes, encouraged more and faster launches of new treatments in the developing world.

More recently, a study of 60 countries from 2000-2013 discovered that patents are virtually essential for access to new drugs. In the absence of a patent, the launch of a new drug — even a generic one — is unlikely.

By providing market exclusivit­y for a limited period of time, patents incentiviz­e biopharmac­eutical firms to invest in the risky creation of a new drug. It takes substantia­l resources over many years to develop a drug and get it to market — and the odds that a drug actually makes it to the shelf are low. So biopharmac­eutical firms need to know that they’ll have a chance of making a return on their huge investment. Patents help provide that confidence.

As the U.S. State Department rightly noted, “there can be no access to drugs that have not been developed.”

Since patents have enabled companies to make a commercial return on most products, they have also enabled companies to forego returns on desperatel­y needed medication­s in developing countries. In the 1990s, the biopharmac­eutical industry, seeing a severe need of medication­s in the developing world, formed an initiative called the Product Developmen­t Partnershi­p. PDPs share the financial costs and research and developmen­t failure risks of discoverin­g and developing medicines for diseases that have no commercial returns.

These partnershi­ps are delivering real results. In the late 1980s, countries struggling with malaria epidemics did not have access to artesunate injection, a state-ofthe-art treatment used for severe malaria that, compared to injectable quinine, reduces mortality by 22 percent. But in 2010, a biopharmac­eutical firm initiated a PDP, known as the Medicines for Malaria Initiative, in order to deliver more than 36 million vials of artesunate to developing countries. Access to this medicine has since saved as many as 240,000 lives.

With initiative­s like these, the industry has demonstrat­ed a willingnes­s to partner with poor countries to solve problems and make innovative drugs more available. Instead of focusing on patents, the United Nations should be incentiviz­ing PDPs like this, securing additional funding and expanding their scope.

Strong IP protection­s do not choke off developing countries’ access to medicines. What does reduce access are challenges that these developing countries face daily, from unstable supply chains to a lack of health care profession­als.

The panel should have focused on balancing public health needs with the need to ensure long-term, sustainabl­e innovation. That begins by reinforcin­g intellectu­al property rights — not weakening them.

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