Archive for July, 2006

AGAP’s response to PHAP’s Leo Wassmer Letter to the Editor

Posted on July 25, 2006. Filed under: Resources |

This is AGAP’s response to the Letter to the Editor (Parallel importation of drugs an unnecessary solution) by PHAP‘s Leo Wassmer that was published on Page A14 of the July 1, 2006 issue of the Philippine Daily Inquirer.


Dear Editor,

This is in response to the letter of Leo Wassmer of PHAP dated 1 July 2006 where they stated that they oppose parallel importation “because it promotes counterfeit medicines and infringes on intellectual property rights.”

Perhaps Mr. Wassmer and the members of PHAP should be reminded that the Doha Declaration on the TRIPS Agreement and Public Health adopted by the 4th Ministerial Conference of the World Trade Organization (WTO) in Doha, Qatar on 14 November 2001 stated that each WTO member country, like the Philippines, is free to establish its own regime for the exhaustion of intellectual property rights without challenge. This means that countries can choose whether to allow or forbid parallel imports as they think best, without fear of a dispute settlement case brought against them before the WTO. Now, for Mr. Wassmer or PHAP for that matter to say that parallel imports infringe on their intellectual property rights only shows their ignorance of this international law principle to which they or their highly-paid lawyers should know about. This means that if Mr. Wassmer and company goes to the WTO on this assertion, their suit would go nowhere. The real reason why Mr. Leo Wassmer of PHAP is objecting parallel importation is because it will decrease MNCs’ market share.

Way back in 2001, the Philippine Government has initiated parallel importation to take advantage of the differential pricing between medicines in other countries, like India, but these efforts have been thwarted by the PHAP through their injunction suits to stop the Philippine Government for these efforts. PHAP should mind their corporate social responsibility and let the Philippine Government and other groups avail of cheaper medicines from other countries. For example, data from the Philippine International Trading Corporation (PITC) dated 16 February 2006 show that a 500 mg tablet of Ponstan, while it costs P21.82 in the Philippines, costs only P 2.61 in India and P 1.38 in Pakistan.

As to the charge that these imports are fake, this is a sweeping statement meant to discredit lower-priced medicines and implant in the public mind that cheap medicines are fake. That is also a great disservice to the Filipino public who suffer from very high drug prices, which is the highest, if not in Southeast Asia, then in Asia.

Even the Commission on Intellectual Property Rights, Innovation and Public Health of the World Health Organization in its Report released last April 2006 stated that developing countries should retain the possibilities to benefit from differential pricing, and the ability to seek and parallel import lower priced medicines.

Thank you very much.

Mr. Jose P. Pepito
President, Nationwide Association of Consumers, Inc.
Ayos na Gamot sa Abot-Kayang Presyo (AGAP) Coalition

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Maligayang kaarawan DZMM!

Posted on July 25, 2006. Filed under: News |

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Medical Terrorism

Posted on July 15, 2006. Filed under: Resources |

by Angelito Mendoza
Published on www.batasnews.com

‘There was a time not long ago that pharmaceutical companies were merely the size of nations. Now, after a frenzied two-year period of pharmaceutical mega-mergers, they are behemoths, which outweigh entire continents. The combined worth of the world’s top five drug companies is twice the combined GNP of all sub-Saharan Africa and their influence on the rules of world trade is many times stronger because they can bring their wealth to bear directly on the levers of western power.’

The Guardian, February 13, 2001

One very classic example of a behemoth is Pfizer. It has become the largest and richest pharmaceutical enterprise in the world when it took over Warner-Lambert – a smaller company and Pfizer competitor — in 1999. It has grown so large that in 2005, its total assets amount to more than US$117 billion and total revenues US$51.3 billion as compared to only US$175 millon in sales in 1965. These are from sales of pharmaceutical products, consumer health care products, and animal health products. It has also in 2005 spent US$7.4 billion for research and development – more than any other pharmaceutical company in the world!

Pfizer belongs to the elite in the pharmaceutical industry whose medicines are also only accessible to the elite. Even with a market like the Philippines, Pfizer keeps its prices of medicines high making Pfizer products accessible only to a small number of Filipinos. It doesn’t care whether the Philippines’ infant morbidity rate remains very high at 35% as long as it keeps its prices and profits high. The Pfizer price is targeted at only the wealthiest Philippine residents – that is no more than the top 5 percent of the population. Like many developing countries with a highly skewed and unequal income distribution, selling to the economic elite at high prices is the profit maximizing strategy for Pfizer.

Pfizer, Ltd. (UK) is the registered owner of Philippine Letters Patent No. 24348 on amlodipine besylate (the “Pfizer Patent”), which will expire on June 13, 2007. Pfizer, Inc. (Philippines) is the exclusive licensee of Pfizer Ltd. in the Philippines (collectively, “Pfizer”).

Pfizer, Inc. has recently filed a civil case against the Philippines International Trading Corporation (PITC) and the Bureau of Food and Drugs (BFAD), and two Philippine government regulators (in their personal capacity!!) before the Makati Regional Trial Court for patent infringement relative to amlodipine besylate marketed by Pfizer under the brand name “NORVASC”

The patent infringement suit, now pending before the Regional Trial Court of Makati, Branch 61, seeks to prevent PITC from immediately offering a generic version of Norvasc after Pfizer’s patent expires in June 2007. Norvasc, or amlodipine besylate, is an anti-hypertension medicine which last year generated more than one billion (yes, billion) Peso sales for Pfizer Philippines. It is a medicine that has to be taken once a day for the rest of one’s life. In the country, Pfizer sells a 5 mg tablet of Norvasc for P44.75 and a 10 mg tablet for P74.50. In contrast, the same product is sold by Pfizer in India under the brand name Amlogard™ at P6.00 per 5 mg tablet and P9.00 per 10 mg tablet, or 650% (for 5 mg) and 730% (for 10 mg) cheaper than in the Philippines!

Competition in the global market is often determined by control over technology, which many transnational corporations jealously guard, often through unfair use of patents, copyrights and so on. Pfizer has long been engaged in a campaign of intimidation to prevent generic competition in the Philippines. It has repeatedly threatened not only BFAD and PITC with lawsuits, but also domestic generic companies. They have also been engaged in an insidious campaign among doctors and the public to denigrate more affordable generic products. This scheme is not new to the Philippines as it is often victimized by transnationals’ patenting materials produced in the Philippines with the benefits not even shared with our country.

What does Pfizer stand from filing the suit against BFAD and PITC? Billions of pesos. In fact, at least two billion pesos of additional sales from Norvasc™ after its patent expires in 2007.

It takes at least 18 months before a generic medicine is approved by BFAD, not counting the protracted delays resulting from interventions made by Pfizer during the drug evaluation process. This means that even if Pfizer’s patent expires in 2007, it can continue to charge monopolistic prices for its Norvasc to the detriment of the Filipino consumers. This is a model Pfizer is sure to replicate when patents over its other products (the anti-cholesterol product Lipitor and the antibiotic products Zithromax and Unasyn) expire.

Ironically, while the United States government points an accusing finger to the Philippines for allegedly not providing enough protection to the intellectual property rights of its citizens, its biggest pharmaceutical citizen is now throwing its weight around, abusing OUR patent system and intimidating our government institutions – all because it wants to maintain its monopoly profits beyond the life of its patent.

This is terrorism in the truest sense of the word — the kind that sows terror to and endangers the lives of 80 million Filipinos.

This must come to an end.

The WTO DOHA Declaration on TRIPS and Public Health upholds the rights of governments to enforce measures that will protect public health. It also gives the States various tools to fulfill public health obligations and ensure access to cheaper drugs. The Philippine Government should continue to use and maximize these policy flexibilities, to ensure that everyone will have access to affordable, quality, and therapeutically equivalent medicines. It is also imperative that PFIZER read and understand these crucial flexibilities. Specifically:

  1. Pfizer should recognize that their patents rights are not absolute. They also have to recognize that there are certain exceptions to patent rights which are provided already in the TRIPS Agreement and reaffirmed in the WTO’s Doha Ministerial Declaration on TRIPS Agreement and Public Health;
  2. Pfizer should respect the right of the Philippine Government which is embodied in the actions initiated by the PITC and BFAD, to take steps that will lead to the lowering of prices of medicines which are already very high in the country, including the parallel importation of branded medicines from countries which produce these medicines at a significantly lower cost than the Philippines;
  3. Pfizer does not have the right to stop the acts of Government including other smaller generic companies from taking steps to develop a generic equivalent to their patented product; these exceptions are already provided for in the Philippines’ Intellectual Property Code.

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Mendoza is convenor of the Ayos na Gamot sa Abot-Kayang Presyo (AGAP) Coalition. He regularly contributes articles and op-ed pieces to www.batasnews.com. You can reach  Mendoza at amendozancl@yahoo.com.

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No Free Lunch

Posted on July 14, 2006. Filed under: Resources |

by Raoul A. Bermejo III, MD

I just received the degree of Doctor of Medicine and these days a new physician has many things to be bothered about –an eroding public image of the doctor, the crisis of health worker migration, and the lack of access of many Filipinos to health care. But while these issues have been often talked about, I would like to raise another that, because it is ingrained in our health care subculture, is often tolerated.

I am bothered by the fact that our class graduation party was largely paid by a drug company. They footed the bill of 150,000 pesos for dinner. Just to be clear about it. It was a party. It was not a scientific meeting. It was not a course of continuing medical education. People went there to eat, drink and be merry.

I am bothered that our class allowed it. It is patently a marketing scheme from the drug company and our class fell for it. Many feel that they are above the issue thinking that they can personally resist being swayed by all these marketing schemes. I think that is being quite naïve. Drug companies utilize these schemes because they work. Clear evidence has shown that physicians’ behaviour in prescribing medication is affected by these enticing efforts of drug companies.

And even if a doctor really can resist being swayed by these marketing schemes, where is the marketing money of drug companies coming from?  Do you really think that it is out of the goodness of their heart? Or their fondness of physicians? Marketing costs are passed on to the consumers and thus are shouldered by patients.  Costs from maintaining an army of cute and dapper medical representatives, and costs from cups of coffee, rounds of golf, lunches, tours, and various freebies that physicians accept contribute to the high prices of medications in the country. All these enjoyable freebies come from the pockets of patients, many of them poor and could hardly afford the complete course of medications their doctors prescribe.

Drug prices in the country are as much as it is in Western Europe, the U.S. and Canada. Our country, having no real pharmaceutical industry of its own, is one of the favourite playgrounds of the three big pharmaceutical firms. They are now challenging even the band-aid effort of our government to make essential drugs accessible to poor Filipinos though parallel drug importation. Expensive marketing schemes compound the problem of unjust drug pricing.

Will making a stand now against an unethical practice really change the situation? Our small daily choices may seem minute to make a dent on what is a much-ingrained practice. But how do we expect the situation to change? Who will make that stand if not us? Our collective stand will matter and will make that change.

There is no such thing as a free lunch. Or a free graduation party.

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Bermejo is 27 years old. He graduated from the University of the Philippines College of Medicine on May 21, 2006. For comments, email him at rabermejo@yahoo.com.

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AGAP Issue Briefing No. 2 – Counterfeit Medicines

Posted on July 13, 2006. Filed under: Resources |

Background

In the first Convenor’s Meeting, Obet Pagdanganan raised the issue of an ad put up by a Pfizer-supported group, the Coalition Against Counterfeit Medicines, which denigrates suspiciously-priced medicines, i.e., low-priced medicines as fakes. DOH said they will check their affiliation with this group and take the appropriate action but the matter of what to do with the ad, particularly the other substantive issues related thereto, such as Republic Act 8203, which apparently serves as the legal prop of the anti-counterfeit medicines campaign,  was left open for further discussion.

In a Talk of the Town issue of the Philippine Daily Inquirer last 2 July 2006, Ping of TWN raised the possibility of amending Republic Act 8203, particularly in the way the imported medicines are classified as counterfeit medicines.

Current Policy Environment

The law banning counterfeit drugs, Republic Act 8203  includes in its definition of a counterfeit drug, “an unregistered imported drug product”. This can be amended  by removing  the unregistered imported drug product as part of the definition of a counterfeit drug, but this leaves open the issue of what should be done with imported drugs that come into the country some of which may also be of dubious quality.

Other aspects of the law on the characterization of counterfeit drugs may also have to be scrutinized whether they would need to be amended, to create  a level playing field for generics medicines.

BFAD may have some rules on the registration of imported drug products and this may have to be examined closely such that they will not unduly hamper the efforts of companies who may wish to import such medicines.

AGAP Action Proposal

A bill amending RA 8203 can be drafted dealing with the issues identified above.

The BFAD can also provide some leeway for imported medicines  to easily come in without being classified as counterfeit drugs.

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