IPR and Medicines 31: Trademark Stealing and Counterfeit Medicines

Today, I will attend the 1st day of National Consciousness Week against Counterfeit Medicines, Theme: Kapakanan ng Pamilya Alagaan, Huwad na Gamot Labanan, to be held at the JY Campos Hall, Bayanihan Center, Unilab Complex in Pasig City. The event is sponsored by the Food and Drugs Administration (FDA) and today's event is mainly for civil society organizations (CSOs), including Minimal Government Thinkers, Inc.

Production of counterfeit, fake and substandard medicines is generally stealing the trademark and logo of famous pharma companies, both innovators like Pfizer and GSK, and generics like Unilab, then selling those fakes. Patients and their family/guardians think that they are buying the real products of these known companies and the patients end up getting some adverse side effects, or they don't get cured and the disease in their body mutate or expand into something more serious. So counterfeits is costly in terms of expanding the treatment, and can be fatal.

As an advocate of rule of law as the main function of government, I believe that government, both national and local units, should be serious in fighting this crime because it endangers public health. This is a more useful function that imposing drug price control and mandatory, forced priced discounts for senior citizens and perons with disabilities (PWDs). Of what use to certain sectors are cheap, forcibly discounted medicines, if they some of them are fake and substandard and  hence, can cause more health problems? Declining prices of  medicines and healthcare can be done by having more competition among more pharma players, among drugstores and hospitals, among physicians and other health professionals.

The topics and speakers for today's event are:

1. Keynote Address by DOH Assistant Secretary, Atty. Nicolas Lutero, OIC of the FDA.

2. "Global Perspectives on Counterfeiting Medicines and the Current WHO Initiatives on SSFFC" by Mr. Michael Deats, Group Lead, SSFFC Medical Products Safety and Vigilance Essential Medicines and Health Products, WHO, Geneva, Switzerland

3. "A Multistakeholder Approach to Strengthening Community Advocacy for Safe and Quality Medicines (Highlights of the MeTA Discussion Series)" by Ms. Cecilia C.  Sison, Country Coordinator, Medicines Transparency Alliance (MeTA) Philippines

4. "Impact of counterfeit medicines to public health and patient safety" by Dr. Maria Minerva P. Calimag, President of the Philippine Medical Association (PMA)

5. "Counterfeiting and its impact to national security and public safety" by Mr. Eric McCloughlin, Deputy Attaché, Homeland Security Investigations, U.S. Immigration and Customs Enforcement (ICE), US Embassy in Manila

6. "Understanding the problem and working together to combat counterfeit medicines" by Mr. Samson Chiu, Director, Asia-Pacific Region, Pharmaceutical Security Institute (PSI)

7. "Food and Drug Administration process and initiatives in combatting counterfeit medicines" by Ms. Maria Lourdes C. Santiago, OIC, Center for Drug Regulation and Research

8. "Enforcement Policies and Regulations on Medicines Anti-Counterfeiting" by Atty. Edna Valenzuela, Senior Assistant State Prosecutor, Department of Justice (DOJ)

9. "Initiatives of Intellectual Property Office of the Philippines in combatting counterfeit medicines" by Atty. Ricardo Blancaflor, Director General, Intellectual Property Office of the Philippines (IPO)

10. Industry’s effort in combatting counterfeit medicines proliferation: 

Best Practices in private industry enforcement programs to stop counterfeit medicines from endangering public

a. Mr. Tetsuda Ikeda, Director Global Security, Asia Pacific Region, Pfizer, Inc.

b. Mr. Teodoro Padilla, Executive Director, Pharmaceutical Healthcare Association of the Philippines (PHAP)

c. Ms. Dolora P. Cardinal, Head, Public Affairs Committee-FDA, Philippine Chamber of the Pharmaceutical Industry, Inc. (PCPI)

Closing remarks by Dr. Ariel I. Valencia, FDA Deputy Director General for Field Regulatory Operations

On the 2nd day tomorrow, the same speakers from the WHO, PSI, US Embassy, others, to be held at Diamond Hotel, Roxas Blvd, Manila. Target audience are mostly government enforcement agencies. And the 3rd day on Wednesday, it will be a pledging session by various groups at the FDA office in Alabang, Muntinlupa.

Meanwhile, some materials on counterfeit medicines I found several years ago:

1. Coalition Against Fake Medicines Launched

The medicines we take for day-to-day ailments and life-threatening conditions should make us feel better or save our lives. But because of the presence of counterfeit medicines in the country today, we should be cautious as to the medicines we buy.

This was the warning issued by the Department of Health (DOH), which noted that about ten percent of medicines bought in pharmacies today are fakes. Fake medicines, which are not registered with the Bureau of Food and Drugs, may be useless, harmful, or even deadly.

This dangerously widespread occurrence pushed similarly-minded government agencies, and private institutions to form a coalition group to help combat and eventually eliminate this illegal trade. The Coalition Against Fake Medicines is composed of ten organizations - the Department of Health (DOH), Department of Trade and Industry (DTI), Department of Justice (DOJ), Philippine Medical Association (PMA), Drugstores Association of the Philippines (DSAP), Mercury Drug Corporation, Zuellig Pharma Corporation, GMA 7 Broadcast Network, Philippine Daily Inquirer and Pfizer. Inc..

Present during the MOA signing were (standing from left): Manuel Quiogue, President, GMA 7 Network, Inc.; Celine Madamba, AVP-Strategic Marketing Communications, PDI; Jack Concepcion, VP-Merchandising, Mercury Drug, Inc; Dr. Jose Sabili, Vice President, Philippine Medical Association. 

Seated from left are Celia Carlos, President, Drugstores Association of the Philippines; Hon. J. Norman Jocson, Assistant Secretary, Department of Trade and Industry; Hon. Manuel Dayrit, Secretary, Department of Health; Rey Gerardo Bacarro, President and Country Manager, Pfizer, Inc; Hon. Macabangkit Lanto, Undersecretary, Department of Justice; and Michael Becker, President and CEO, Zuellig Pharma Corporation.

2. From The News Today, 2006.

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See also:
IPR and Medicines 27: More on Glivec and India's SC Decision, April 02, 2013
IPR and Medicines 28: Politicizing Innovation, Rewarding Rent-Seeking, April 06, 2013
IPR and Medicines 29: Parallel Importation and Patent Linkage, August 19, 2014
IPR and Medicines 30: R&D and Innovator Companies, November 03, 2014

EMHN 6: Fake Medicines in Asia

Our regional health group, the Emerging Markets Health Network, has produced a new paper, EMHN Briefing No. 1: Fake Medicines in Asia. Authored by Philip Stevens and Helmy Haja Mydin, the paper has argued that 

Fake medicines - which are either criminally motivated or the result of lax manufacturing standards - are a worsening problem, particularly in Asia. In some of poorer parts of the continent, up to a quarter of medicines fail quality tests. 

Evidence shows that cheap generic drugs are the most faked medicines in Asia, although there appears to be a particular problem with anti-malarial drugs in places such as Laos and Cambodia. China and India appear to be production hotspots. 

Producers and purveyors of fake medicines are exploiting the increasing globalisation of the pharmaceutical supply chain, poorly defined and  enforced civil and criminal laws, and a lack of an international definition
of what legally constitutes a fake medicine. 

Below is one of the graphics contained in the report. About 40 percent of the pharma crime incidents in 2011 occurred in Asia, followed by Latin America and Europe. I am just wondering why incidents in Africa constituted only three percent of the total. This could be a result of under-reporting of such incidents in Africa, or other factors.

The presence of counterfeit or substandard drugs is a problem here in the Philippines. One time, an anesthesiologist friend told me, a patient was lying on the operating table, surgeons were about to slice his tummy, so the anesthesiologists come first before them. The injected substance is supposed to make the patient feel numb and sleep, within minutes. But after giving the necessary dosage, the patient was still awake and numbness was light. He would be shouting in pain if the surgery would proceed. They realized that they got a fake or substandard anesthesia from one local pharma company that was purchased by the hospital. Right there and then, they scrambled to get another anesthesia as the surgery must proceed that day, otherwise the patient's condition will deteriorate.

So the doctors wrote tot he FDA in a confidential letter to complain about the product of this local company, and the latter knew about their letter, they must have a "mole" inside the agency. This company threatened to sue the doctors for criticizing their company. I offered to write about the story but the physicians were hesitant to give me full details as it is still under FDA investigation. 

The report did mention about the case of fake medicines in the Philippines.

How to solve this increasing problem? The usual solution by many groups is... more legislation, more government. The authors, and I agree with them, caution against this move. They wrote,

In countries where the rule of law is weak, the creation of new regulatory layers and tougher criminal sanctions may be counterproductive, as new powers for regulators create opportunities for bribery and corruption.   

To be effective, stiffer criminal penalties depend on an efficient and fair rule of law, something which does not exist in many Asian countries, particularly the poorer ones which have the greatest problem.

Stronger criminal penalties will likely drive activities further into the hands of organised criminal cells and will also likely result in further corruption, as the criminal cells seek to infiltrate law-enforcement agencies. The fake medicines trade is already showing worrying signs of mafiaisation, with organised crime groups such as Chinese triads and Mexican drug gangs all becoming implicated in the trade over the past decade. 

More effective solutions must address its fundamental cause, which revolve around the inability of legitimate manufacturers to protect the integrity of their brands. Legal reforms can go some way towards addressing these problems, as can innovative uses of technology. 

Protection of intellectual property rights (IPR) like patent and trademarks, enforcement of existing laws against such bad practices, or simply promulgate the rule of law, is the best thing that governments can do, not the creation of new and more regulations and laws.

Civil society groups concerned with or engaged in public health issues would better focus their energy more in battling this bigger problem of proliferating fake medicines, instead of circumventing or disrespecting IPR. As the report noted, the more faked medicines are the known branded generics more than the innovator drugs.

EMHN is a project of the Institute for Democracy and Economic Affairs (IDEAS) in Kuala Lumpur.
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See also:
EMHN 2: IDEAS Forum in Penang, Malaysia, September 01, 2012
EMHN 3: Penang Workshop Report, September 10, 2012
EMHN 4: Free Trade, TPP and Public Health Protection, January 13, 2013
EMHN 5: Free Trade and Markets in Healthcare, January 17. 2013