Industry use of WHO Model List of Essential Medicines as defense against patent abuses

The following are some quotes by countries, companies, academics and other actors stating, suggesting or implying claiming that drugs not on the WHO Model List of Essential Medicines (WHO EML) should not be subject to a compulsory license.

Bayer. Political Principles.

http://www.bayer.com/en/innovation-requires-investment.aspx
Political Principles.
Innovation requires investment.
Good ideas must be worthwhile.

Patents are an essential incentive for investment in the research and development of new products and technologies. Protection against product imitation for a limited period of time is in everyone’s interests: investment has time to pay off, and once the period of protection has expired the innovation be used by all.
Patent protection is a prerequisite for an efficient healthcare system, since without it hardly any drugs would be developed. Furthermore, over 90% of what the World Health Organization calls ‘essential medicines’ have long-since been out of patent and are offered by various companies worldwide.

Bayer Performance Report Innovation & Product Stewardship

http://www.sustainability2011.bayer.com/en/innovation-and-products.aspx (accessed September 24, 2014)
News
Patent dispute concerning Nexavar in India

The Indian patent authorities in March 2012 granted Indian generics producer Natco a compulsory license for the Bayer cancer drug Nexavar™. Bayer does not consider that the requirements are in place for the granting of a compulsory license and will appeal the decision by the patent authorities in order to defend its patent rights. The Indian health system indisputably faces particular challenges as regards medical care for the country’s population. However, these challenges are hardly connected with pharmaceutical product patents, as none of the drug products on the Indian list of essential pharmaceuticals is patented.. The granting of compulsory licenses alone therefore cannot solve the problems facing the Indian health system. Instead, the decision is harmful to the international patent system and thus threatens pharmaceutical research in the long term. After all, investment in the research and development of both innovative drug products and future therapies can only be financed through patent rights.

There should therefore be a closer focus on allowing patients direct access to innovative drug products. Since introducing Nexavar™ in India, for example, Bayer has offered a patient assistance program that is regularly expanded. As part of this program, needy patients are currently supplied with Nexavar™ at approximately 10 percent of the pharmacy price. Patients receive advice from their attending physicians based on their therapeutic response to the drug and their financial situation.

April 2011 briefing note from GSK

http://www.gsk.com/content/dam/gsk/globals/documents/pdf/GSK-on-IP-and-access-to-medicines-in-developing-countries.pdf

Patents as a Barrier to Access

To focus on patents as a barrier to access is misleading and counter-productive. Patent protection stimulates and fundamentally underpins the continued research and development for new and better medicines for diseases including those which occur in the developing world.

. . . over 95% of the 325 drugs on the WHO Essential Drugs LIst (EDL) are not patent protected and yet the WHO says taht 30% of people in developing countries do not have reliable access to these drugs. . .

April 2011.

Access to medicine for patients in need : Novartis perspective

http://www.novartis.com/downloads/corporate-responsibility/resources/positions/access-to-medicine.pdf (accessed Jan 24, 2014)

Access to medicine for patients in need - Novartis perspective

Barriers to access

For a research-based healthcare company, intellectual property protection is essential for sustainable success. Intellectual property protection is not the main barrier to access in developing couintris: More than 300 of 319 drugs on the World Health Organization's model list of essential drugs lack patent protection. Still, more than one-third of the world's population has limited or no access to these medicines.

Public Policy Statement: Intellectual Property and Access to Medicines in the Developing World Merck. 2011, Merck.

http://www.merck.com/about/views-and-positions/public-policy-statement-ip-2011.pdf

Public Policy Statement: Intellectual Property and Access to Medicines in the Developing World Merck. 2011, Merck.

The vast majority of medicines on the WHO's essential drugs list have generic versions available (Health Affairs 2004; 23 (3): 155-166).

2001

Amir Attaran, Lee Gillespie-White, Do patents for antiretroviral drugs constrain access to AIDS treatment in Africa?, JAMA. 2001 Oct 17;286(15):1886-92.

Abstract: Public attention and debate recently have focused on access to treatment of acquired immunodeficiency syndrome (AIDS) in poor, severely affected countries, such as those in Africa. Whether patents on antiretroviral drugs in Africa are impeding access to lifesaving treatment for the 25 million Africans with human immunodeficiency virus infection is unknown. We studied the patent statuses of 15 antiretroviral drugs in 53 African countries. Using a survey method, we found that these antiretroviral drugs are patented in few African countries (median, 3; mode, 0) and that in countries where antiretroviral drug patents exist, generally only a small subset of antiretroviral drugs are patented (median and mode, 4). The observed scarcity of patents cannot be simply explained by a lack of patent laws because most African countries have offered patent protection for pharmaceuticals for many years. Furthermore, in this particular case, geographic patent coverage does not appear to correlate with antiretroviral treatment access in Africa, suggesting that patents and patent law are not a major barrier to treatment access in and of themselves. We conclude that a variety of de facto barriers are more responsible for impeding access to antiretroviral treatment, including but not limited to the poverty of African countries, the high cost of antiretroviral treatment, national regulatory requirements for medicines, tariffs and sales taxes, and, above all, a lack of sufficient international financial aid to fund antiretroviral treatment. We consider these findings in light of policies for enhancing antiretroviral treatment access in poor countries.

2004

Attaran's 2004 Health Affairs paper. (the data from this paper was presented as a PhRMA document earlier at a workshop by Tom Bombelles).

May 2004, How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?, Amir Attaran, Health Affairs, 10.1377/hlthaff.23.3.155
Health Aff May 2004 vol. 23 no. 3 155-166.

This study tests the extent to which pharmaceutical patents in developing countries can thwart access to essential medicines. This can be done by quantifying the frequency with which “essential medicines,” as defined by the World Health Organization (WHO), are patented in low- and middle-income countries, emphasizing Africa, where access to medicines is the worst. I examine these data by statistical methods, to identify correlates of patent practice and access to medicines. Briefly, I find that patents for essential medicines are uncommon in poor countries and cannot readily explain why access to those medicines is often lacking, suggesting that poverty, not patents, imposes the greater limitation on access.

2012

23 March 2012, US statement to WIPO Standing Committee on Patents (SCP) on the United States proposal on Patents and Health

Weakening patent protection for innovative medicines is not a productive approach to improving availability of health care, because many other factors other than patents more directly affect the availability of medicines. . . .

The proof of the weakness of that argument is that although most medicines on the World Health Organization’s List of Essential Medicines are not protected by patents, their availability in many markets is still limited. This is particularly true in DC/LDCs. Many other factors affect the availability of all medicines, patented or not.

2013, Bayer statement in ip-watch

5 March 2013, Bayer Will Appeal India Compulsory Licence On Its Cancer Drug, Intellectual Property Watch.

The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India’s essential drug list are not patented,” Bayer said. “One of the main barriers to access to medicines in developing countries such as India is the lack of adequate healthcare services and infrastructure ensuring that drugs will effectively bring treatment to those who most need it.”

2013 Bayer quote in Economic Times

12 October 2013, Bayer challenges IPAB’s compulsory licence order to Natco Pharma on cancer drug Nexavar, Bayer challenges IPAB’s compulsory licence order to Natco Pharma on cancer drug Nexavar, Economic Times.

"We strongly disagree with the conclusions of IPAB," said Bayer spokesperson to ET's email query. "Bayer is committed to protecting its patent for Nexavar. We will rigorously continue to defend our intellectual property rights within the Indian legal system. The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India's essential drug list are not patented. The order of IPAB weakens the international patent system and endangers pharmaceutical research."

Roche briefing document

http://www.roche.com/responsibility/access_to_healthcare/making_innovation_accessible/ath_who.htm (accessed January 24, 2014)

Developing essential medicines

Twenty-four medicines developed by Roche are included in the WHO Model Lists of Essential Medicines. Twenty-two of these are patent-free and include life-saving antibiotics, anti-malarials and chemotherapy.

The WHO core list contains medicines believed to be required for a basic healthcare system, including the most efficacious, safe and cost effective medicines for priority conditions. The WHO Model List serves as a guide for the development of national and institutional essential medicine lists.

2012

Tim K. Mackey and Bryan A. Liang, Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease, Plos one. November 30, 2012DOI: 10.1371/journal.pone.0051022

We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global populations for these essential medicines.