ETHIKOS 1: MeTA-PH, PCPI, PHAP and FDA on launching

(Note: This is an expanded version of the paper that I wrote last Friday.)

Last Thursday night, the ETHIKOS (Ethics in Healthcare) Movement was launched at C3 Events Place in Greenhills, San Juan, Metro Manila. Many participants from different groups and sectors. Some quotes from some speakers that night.

All photos I got from the MeTA Philippines facebook page. Thanks Ian Nuevo.

1. Former Gov. Roberto “Obet” Pagdanganan, MeTA Philippines Chairman

Gov. Obet thanked the participants, particularly the organizations that formed movement – the Medicines Transparency Alliance (MeTA) Philippines, the Coalition for Health Advocacy and Transparency (CHAT), and the British Embassy’s Foreign and Commonwealth Office (FCO).

Then he introduced the Convenor Group of the ETHIKOS Movement: (1) Princess Nemenzo of WomanHealth, (2) Celia Carlos of the Drugstores Association of the Philippines (DSAP), (3) Girlie Lorenzo of Kythe Foundation, also of the Philippine alliance for Patient Organizations (PAPO); Tony Leachon of the Philippine College of Physicians (PCP), and himself.

He discussed what ETHIKOS is – a movement to encourage ethics in delivering healthcare to the patients, ethics in dealing with healthcare professionals  and other private players in the sector, ethics in government.

2. Atty. Dave Escalona, Philippine Chamber of Pharmaceutical Industry (PCPI) and United Laboratories

Dave said that the local pharma industry is supporting the Mexico City Principles (MCP) for voluntary codes of business ethics in the biopharmaceutical sector. He introduced a similar term, “Manila Principles” where the basis of such code of ethics are the Generics Act of 1998 and the Cheaper Medicines Law of 2008 (RA 9502), and the object of such ethics is the welfare of the patients.

Thus, the Manila Principles should consider TRIPS flexibilities as contained in RA 9502, avoid whenever possible prolonged data exclusivity, disallow frivolous patents, allow early working of soon-expiring patents of innovator drugs. He lamented that many local pharma companies are small and lesser known compared to big multinational pharma.

3. Teodoro “Ted” Padilla, Pharmaceutical and Healthcare Association of the Philippines (PHAP) Executive Director.

Ted narrated that in 1993, the association introduced and adopted a code of ethics called the PHAP Code of Practice. He quoted the late Doc Alberto “Quasi” Romualdez (a former DOH Secretary, founding chairman of MeTA PH) who said that “The most important achievement of PHAP now is that they have made ethical behaviour an import part of their commitment…”

He emphasized that no amount of health reform will be truly universal if people and players ignore the consequences of unethical behaviour. He also expressed support for the FDA to implement the MCP. Then he mentioned the important role of the innovator companies for endlessly producing new medicines which help save lives and improve the quality of life of Filipinos.

4. Kenneth “Ken” Hartigan Go, Food and Drug Administration (FDA) Director-General.

Doc Ken discussed certain FDA guidelines regarding senior government officials (SGOs) who make follow up calls at FDA. There are four possibilities where SGOs:

(a)     to inquire on behalf of his/her private sector associates, or determine the status of a rival company

(b)     to request earlier facilitationof application (expediting or jumping the queue

(c)     to demand aprovals even if the license or product registration is to be denied, or to demand a denial against a rival company, and

(d)     to reverse a regulatory decision.

My comments to some of these points in my next article about ETHIKOS..

Generic Drugs 4: DOH Generics Summit 2013

The Generics Act of 1988, RA 6675, turned 25 years old last month. The Department of Health organized the "Generic Medicines Summit 2013" at the DOH Convention Hall, DOH Compound, Manila last Monday, September 30, 2013. It was a whole day activity, I was not able to attend the morning session, I went to the afternoon sessions.

Panel Session No. I, 1-2:30pm, the theme was “The Impact of Generics Policies in Improving Access to Medicines and Health Outcomes”. The speakers were:

Presentation No. 1: Global Achievements in Implementing Generic Policies Presentation No. 2:Local Market Trends Presentation No. 3: Analysis of the Prescribing and Dispensing of Generic Medicines as Prescribed by Generics Act of 1988 Panelists: PCPI, PHAP, PPhA

Dr. Brian Godman Mr. Romeo Castro, GM, IMS Health Phils., Inc. Dr. John Q. Wong, Consultant, PIDS

Panel Session No. II, 2:30-5pm, the theme was “Progress of Pharmaceutical Reforms and  Continuing Efforts of Government in  Assuring Availability and Affordability of  Quality Generic Medicines”. The speakers were:

Presentation No. 4: Impact Evaluation and Monitoring of the Cheaper Medicines Act of 2008 Presentation No. 5: The Impact of the Cheaper Medicines Act on Households in Metro Manila:  A Quarterly Study” Presentation No. 6: Philhealth’s Initiatives in Promoting and Using Generic Medicines Presentation No.7: FDA Efforts to Assure the Quality of Generics in the Market

Dr. Jesus N. Sarol, Jr. Consultant, PCHARD Dr. Eleanor De Guzman Research Consultant, PIDS Dr. Poch Soria Vice President, PHIC Dr. Kenneth Hartigan Go Director General, FDA

The panel of reactors were Dr. Delen de la Paz of HAIN and UP College of Medicine, Dr. Isidro Sia of the National Formula Board, also of UPCM, and Atty. Pau Tanguieng of AGAP. Pau was not around, Before panel 1 ended, Dr. Melissa Guerrero of NCPAM asked me if I can be a reactor, speak as representative from civil society. It’s not a difficult task, I quickly said Yes.

So I was seated in the front table beside Docs Dela Paz and Sia, have a good view of the speakers and their presentations. Nice.

Dr. Sarol and Dr. de Guzman spoke about their respective assessment reports about drug price regulation of the Cheaper Medicines Act (CMA) of 2008, FDA Director KHGo spoke about the reforms that FDA is doing, and Doc Soria spoke about new thrusts of PhilHealth.

My comments to the four presentations:

1. Dr. Jesus Sarol presentation...

Their study covering 2009-2011 simply confirms what we already know, that medicine prices are just following the law of gravity, they are coming down. In fact even before CMA became a law, ave medicine prices have been declining slowly, thanks to that good old reliable law of competition.

I added that CMA is more than drug price regulation or control. The law is mainly revising the Intellectual Property Code (IPC) of the country to accommodate compulsory licensing (CL) and other IPR concerns.

2. Dr. Elanora de Guzman paper:

Good findings in their study, confirms that the main beneficiaries of the drug price control policy were the upper middle class and the rich, class AB and C, not the poor, class DE. Before price control was imposed, many cheaper generic drugs were available, so when Pfizer's Norvasc (anti-hypertension) price was forced down from P44 to P22 a tablet, there were several generics already selling at P7.50 or lower. The poor will find the P22 still expensive and won't buy it, they'll go for the P7 or P5 other branded generics.

3. FDA Director, Doc KHGo:

Happy that FDA is promoting the rule of law in ensuring the safety of food, medicines, drinks, other consumer (chemical, biological) products, law based on science. Congratulations.

But it is simply impossible for FDA to monitor all such products, from anti-cancer medicines to barbeque sauce or new energy drinks or skin whitening soap, etc. Commiserations. The number of products to be monitored and approved is directly proportional to their misery.

One option is to partner with private or civil society accreditation bodies, also industry associations, that will police their own ranks and disallow unsafe products from being manufactured and sold. This way, FDA can focus its resources and manpower on firms and products that are not covered by those private or civil society accreditation bodies and industry associations. Spot checks by FDA to these bodies, so that repeated cases of unsafe food and drugs being allowed will mean revocation or blacklisting of such bodies, and firms will have to go through the usual, stringent FDA approval process.

4.  Dr. Poch Soria:

PhilHealth is somehow a victim of its huge and monster existence, there is also monster expectations, monster disappointment by the public. The more they promise to do something or correct past inadequacies, the more expectations and even more loopholes that will be introduced.

Their data that of the 315 govt hospitals they surveyed (42 DOH hospitals + PGH, and 273 LGU hospitals), only 7% complied with the no balance billing (NBB) for indigent patients. 93% of them required out of pocket (OOP) spending by the poor. This shows that often, government is a big violator of its own rules.

PhilHealth then should learn to step back on certain promises, reduce the expectations. One area is on NCDs (non communicable diseases) patients. Someone with communicable disease like dengue is easy to treat, after the disease is killed, a patient won't go back to the hospital for several/many years. Compare that to a hypertension or other adult NCD patient, who will be patient for the next 10, 20 years or more. Can drain the reserves.

FDA 6: Business and Modernization Plan

The Food and Drugs Administration is technically a very powerful government agency because it can say Yes or No to the introduction of new medicines and vaccines, innovator or generic; new food supplements and drinks; new skin whiteners, boobs enlargers, soap and shampoo, toothpaste and lotions, medicines and vitamins for animals and fishes, medical and dental devices, and many other things.

So a vigilant and technically capable FDA can block the introduction of those “magic” tea/coffee or herbal drinks that can “prevent or cure all types of cancer, all types of cardiovascular diseases…” and penalize violators, those who introduced those “magical, cure all” products without FDA permission and make big money fooling the public and putting the health of some patients in danger .

Yesterday, I attended a presentation by the FDA headed by its Director, Dr. Kenneth Hartigan-Go, held at the Asian Institute of Management (AIM) in Makati. The event was sponsored by the Medicines Transparency Alliance (MeTA) Philippines, in coordination with the Stephen Zuellig Center for Asian Business Transformation.

He presented this paper, but in powerpoint form. This blog post by the way, is 7 pages long including photos and illustrations, so enjoy.

This paper is straightforward and frank. For one, it explicitly admits that the old FDA set was corrupt and fomented corruption. Hats off to the new FDA guys, led by Dr. Ken, for this admission. Undesirable acts can be corrected if the mistake is explicitly recognized in the first place. The paper said,

Why did the old FDA setup foment corruption? The old FDA is a web of misinformation, dead-ends and inconsistency. Companies who seek to be authorized encounter an ill-defined and dated body of regulations. With a bureaucratic process and indefinite deadlines, application turnaround times are known to exceed two years from lodging in of application to release of authorization. This alone translates to losses for companies who cannot operate and are forced to deal with overhead costs without revenues. In their efforts to avoid dealing with the FDA, middlemen (i.e. freelance regulation consultants) have risen to exploit the market of frustrated industry people taking advantage of the lack of transparency, inconsistency with regards to requirements and evaluation process, and the plain distance of the FDA from company offices in central NCR. While not all middlemen are unscrupulous, the agency’s tarnished reputation has been used as an excuse for the middlemen’s own shortcomings. Unfortunately, the old FDA cannot refute the allegations for it is all true – the process is corrupt, the system is sclerotic and the leadership wanting.

These are the four core reforms that the FDA is banking on. And each major heading has many parts or action items.

On (1) Improving the evaluation process, I was very happy to see those “paperless application”, “electronic payment”, “online application guidelines”, “automated renewal of licenses”. Yes, show the paper trails, remove or minimize the face to face interaction between the regulator and those regulated. Transparency alone reduces the itch for corruption and actual commission of corrupt practices.

On (2) Enhancing regulatory inspection, FDA is getting serious on having rule of law, it is one big good news. Make the inspectors more technologically sophisticated and accountable, more bold, prepared and even armed, and have a strong legal team, prosecute violators.

In a brief open forum after Doc Ken’s presentation, I spoke and lauded this new move. FDA is saying to potential violators that “Go ahead, sell and distribute fake or substandard medicines, adulterated foods, etc. and face our lawyers.” The threat of being legally prosecuted when found violating the rules is a stronger deterrence than pre-business inspections.

FDA 5: Trade and Investment Promotions

Today, the Food and Drug Administration (FDA) will celebrate its 50th Anniversary at its office in Alabang. Congratulations, FDA Director Dr. Kenneth Hartigan-Go and staff.

Doc KHG has a new slogan, a "Transformative FDA" where they are "finding the balance between innovations and sound regulations."

I think it is a good and simple goal. Encouraging innovations while weeding out the not-so-good guys among the players via regulations and penalties for violation of certain rules.

Last Monday, June 17, FDA held a training seminar for its top officials and decision makers from different centers and offices, with resource speakers from the Board of Investments (BOI, DTI) and the Bureau of Customs (BOC, DOF). The goal of the training and discussion is to further develop FDA as an "agency that is conscious of its important role in facilitating trade of goods and services as well as in promoting investment in the country.... securing public health (and) be a more trade and investment-friendly agency in order to support growth and development of the industry, promote national competitiveness and sustain economic gains of the country."

I saw the FDA Press Release on the activity. A BOC official and speaker, Mr. Villanueva,  focused on "Ease of Doing Business, discussing the importance of time, cost, and documents as far as business registration is concerned." 

Bureaucratic regulations are realities happening almost anywhere in the planet that we have to live with. If kept to the minimum, such regulations and prohibitions will drastically help reduce unethical or abusive business practices that can disadvantage consumers as both the players/regulated and the regulator can easily remember only a few regulations, not dozens or hundreds of them.

One important precondition for the rule of law to prevail is that the laws and regulations should be as general (ie, not so detailed) in application and as few as possible in number. To promote economic freedom and more entrepreneurship, more job creation, everything should be allowed, except for a few expressly and explicitly prohibited acts like stealing, killing, abduction, explicit plan to fool the consumers, and a few others. The penalties should be very clear and should apply to all violators, no one is exempted and no one can grant an exemption. That is the essence of the rule of law.

In the case of the FDA, its main function is to allow and encourage the entry of more players, manufacturers, distributors and retailers, who will give the public more useful food, drinks and medicines at competitive prices, and weed out players that produce and sell products that can be harmful to the people. This way, public health will be further promoted.

It is important for the FDA to have a strong legal team that can prosecute at a short period of time those caught violating its rules and regulations. Or at least, it should have strong tie up with the Department of Justice, the police and the courts, so that legal cases against violators or plain suspects can be pushed with little or no delay.

This act alone will encourage the entry of more players both from abroad and from local entrepreneurs, to enter the food and drugs business, as they see the equal application of the law to unequal people and players, and the opportunist and shrewd among them will be culled and removed.

So good luck, Doc Ken and your staff at the FDA.
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See also:
FDA Watch 1: BFAD Strengthening Bill, May 06, 2009
FDA Watch 2: Inspection of cGMP Compliance, January 31, 2011 
FDA Watch 3: Retirement of Dr. Suzette Lazo from FDA, May 16, 2012 
FDA Watch 4: Dr. KH Go Lecture on Regulation and UHC, May 06, 2013

FDA Watch 4: Dr. KH Go Lecture on Regulation and UHC

Last April 12, 2013, Food and Drugs Administration (FDA) Director, Dr. Kenneth Hartigan-Go gave a lecture at the AIM, part of the MeTA Philippines discussion series. I was not able to attend it as I attended a lecture on mining taxation at UP Diliman that afternoon. So my discussions below will be limited to his presentations. The 69-slides presentation is available here.

Dr. KHG's talk started with photos and lessons from the movie, "The Untouchables". The lessons were very telling, like:

Walls have ears. Colleagues could be moles. Information from one trusted source could be wrong. Intel is critical but can you trust your boss? Media sometimes gets into the way of your operations. A good regulator can also experience fear (and temptation). Sin of omission is equally as dangerous as commission of crime. The Modus Operandi of Evil – bribe, extort, threat and lastly, harm.

This illustration or model below caught my attention. There is (government) regulation but nothing on (players) competition. Not everything can be provided or regulated by the government. Competition among players is often the best self-regulation that players do, they cannot over-price or sell inferior or harmful products as the customers can boycott them anytime, if not haul them to court. I will make no comments to the next two slides.

It is good that Doc KHG used the term "coercive power of the state" as government by nature, is force and coercion. It is not a voluntary organization like a tennis club or running club or rotary club that one can join and pay annual dues, then quit membership and stop paying the dues. And Yes, regulation is coercion. It is prohibition, telling players -- corporations, NGOs and individuals -- that certain things are prohibited and limited, and there are penalties for violating the regulations.

The illustration below shows the four elements of regulation. No comment.

These ethical considerations are informative. They present certain dilemma to regulators. If people are allowed to free ride, they will. Like non-poor people to get UP education subsidy or DOH and PhilHealth subsidy, and keep more of their money for various personal spending. That is why government subsidies should be limited whenever possible.

About the practice of certain physicians who prescribe and dispense at the same time certain medicines and vaccines, there is indeed some "conflict of interest" there. Like they will use medicines and/or vaccines where they can get the maximum profit margin. But in certain cases, that is not the end of the story. The physicians who do this would also bend backwards and exert extra effort to serve their patients. Like spending an hour with the patients and their parents/guardians instead of the usual five-minutes visit then call the next patient waiting outside. Or they make sure that the medicines to be administered are well-handled/transported and well-stored before being finally given to the patients.

Socialized Healthcare 7: Degnan and Wagner on ICIUM and UHC

Healthcare is a very important issue for many people around the planet. That is why emotional arguments are often linked with quantitative and political discourses. The belief or motto that "health is a right and an entitlement from the state" often clouds if not erases the other side of the equation that health is also a personal and parental/guardian/civil society responsibility.

Yesterday, I attended a seminar at the Asian Institute of Management (AIM) by two eminent speakers from Harvard Medical School (HMS) and World Health Organization (WHO) consultants.

Dr. Ross-Degnan, Sc.D. (left photo), an Associate Professor at the Department of Ambulatory Care and Prevention (DACP) at HMS and Director of Research at Harvard Pilgrim Health Care, spoke on Improving Medicines Access and Use: Highlights from the International Conference on

Improving Use of Medicines (ICIUM 2011).

Dr. DegNan co-founded the International Network for Rational Use of Drugs (INRUD) in 1990, a global network of academics, health managers, and policymakers involved in developing and testing interdisciplinary interventions to improve use of medicines. He is a consultant at the WHO on issues related to access to and appropriate use of medicines, and pharmaceutical sector monitoring and evaluation. 

The second speaker was Dr. Anita Wagner (above, right photo), an Assistant Professor in the Department of Ambulatory Care and Prevention (DACP) at HMS and Harvard Pilgrim Health Care. She has a doctorate in epidemiology from Harvard School of Public Health and a doctorate in clinical pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences. For the WHO Collaborating Center in Pharmaceutical Policy, she leads the global Medicines and Insurance Coverage (MedIC) Initiative. Yesterday, she spoke on Universal Coverage and Medicines: Why Focus on Value?

A staff of Dr. Kenneth Hartigan-Go of AIM, David Teh, sent me the powerpoints today. Thanks David. Dr. Degnan's presentation is about 30 slides, I will show only about half of them below.

Improving use of medicines (IUM) I think is the other term for rational use of medicines (RUM). The latter is used here by the DOH and even by WHO Philippine Office. Right, even if medicines are heavily subsidized by the government, or even freely available, a patient should not over-dose or over-extend taking the medicines simply because they are cheap or free. There are serious long term adverse effects like anti-microbial resistance (AMR) where the body or a disease has gotten used to certain medicines and treatment and simply multiply or evolve into more dangerous diseases even if the patient is taking the necessary medications. The chart on supply and demand of medicines by Dr. Degnan is nice. I think it's simple enough.

Dr. Degnan gave a background about the ICIUM, it holds the conference every seven years. So the next conference would be sometime in 2018. And from 2003 to 2007, there was marginal improvement in policies and implementation of countries to improve use of medicines.

Below are the series of recommendations for each sector or stakeholder. I like the one mentioning the role of think tanks. We don't have much of such stuff here in the Philippines. We instead have dozens or hundreds of advocacy NGOs and people's organizations and cooperatives with definite positions on certain issues that are often not refined or updated with the changing times.

Then I like the mention or emphasis on multi-stakeholder collaboration, the unintended adverse effects of government intervention in pricing of medicines, like the current drug price control and mandatory 20 percent discount to senior citizens and persons with disabilities (PWDs).

PhilHealth Watch 7: Deregulate PhilSick

(Note: Check my previous discussions on the "PhilHealth Watch" series as backgrounder:

Part 1: Claims vs. reimbursement, August 25, 2010
Part 2: Contributions vs. Service, September 24, 2010
Part 3, Market failure vs. Government failure in health insurance, October 13, 2010
Part 4: P110 B excess money, November 04, 2010
Part 5: Healthcare and Civil Society, May 06, 2011
Part 6: Bogus Claims and Robbery, June 15, 2011)

Last Thursday, October 6, there was an interesting forum on the Senate Bill amending the PhilHealth Charter organized by MeTA Philippines, inviting CHAT's NGO leaders. The presenter was Dr. Kenneth Hartigan-Go,  Executive Director, Zuellig Center for Asian Business Transformation, AIM Center for Development Management. and former Secretary of MeTA Philippines. The audience were varied -- from health NGOs, research NGOs (like IBON and MG Thinkers), WHO, PhilHealth, PHAP and a few multinational pharma, and the Phil. Pharmacists Association (PPhA).

Dr. Ken mentioned several issues about PhilHealth and the government-run health insurance system. Among them:

1. Still high out of pocket (OOP) spending,
2. Poor premium collection and poor insurance coverage,
3. Little funds for preventing and primary healthcare,
4. Some effects of devolution of healthcare to LGUs,
5. Accountability of PhilHealth administration
6. High OOP partly due to less essential if not useless health products like cosmetics, vitamins, even unnecessary hospitalization,
7. Possible rise in premium contribution by 3.5 percent or 5 percent for those in the formal sector,
8. Mapping of informal sector by the LGUs.
9. Goal of reducing OOP to 20 percent of total health expenditure (THE) by 2020,
10. Others.

The exchange among participants were rather very spontaneous and lively. I like the term "PhilSick" because one can "enjoy" getting PhilHealth reimbursement only if he/she is already very sick and confined in a hospital. If one is not confined in a hospital, he/she cannot file for claims and reimbursement.

After listening to various exchanges, my time to speak and I focused on the following:

1. We are already double- or triple-taxed on health: (a) income tax and consumption tax (VAT, etc.) to help finance the DOH, its retained hospitals, hospitals and healthcare by LGUs, (b) PhilHealth mandatory contributions, and (c) getting a private health insurance via health maintenance organizations (HMOs) and other schemes.

2. For me personally, the most useless is (b), PhilHealth. I have been working for the past 25 years or so, been contributing to Medicare before (it went bankrupt) now PhilHealth, and I've never been hospitalized all those years. My family members are supposed to be my "dependents" but my wife also has work, so she is also a PhilHealth member. When she gave birth, she was hospitalized of course, she claimed on her membership and the reimbursement was small, something like 1/7 of the total hospital bill.

3. With due respect to the PhilHealth guys in the room, PhilHealth is simply a monster bureaucracy that tends to behave like most bureaucracies - they exist mainly for themselves. See for instance how secretive it is with regards to the perks and bonuses of its Directors, how defensive and jealous it is in limiting membership of the Board to a few, mostly government officials too, people. The regulated sectors and players like the physicians and hospitals, are out of the Board. I also have personal experience in queueing for 2-3 hours just to file for claims, or another 2-3 hours just to get a membership data record (MDR). PhilHealth wants contributions to be sent to them in minutes (one can text his contribution to the bureaucracy) but members have to wait 2 to 3 months or more to get the reimbursement at a smaller amount compared to total hospital bill.

4. Many in the formal sector have to get a private insurance. If I have a persistent fever or bad cough, I cannot just go to any DOH hospital for they are far from my office; I also cannot file for claims with PhilHealth as I don't get hospitalized. I use my HMO card and it's convenient and useful.

5. To attain "universal healthcare" (UHC), it is important that people should have health insurance, whether government-run or private or NGO- or cooperative-managed. Thus, UHC should not mean government health insurance monopoly.

6. Thus, contrary to the advocacy of many in the room asking for bigger but a "reformed" PhilHealth, I think a better alternative is to deregulate the health insurance industry. PhilHealth will not be abolished, it can be retained as a government health insurance corporation but no longer a monopoly and membership to it will no longer be mandatory and by coercion. If PhilHealth sees that they are no longer attracting the public, it will be forced to become efficient and be more sensitive to their contributors and clients.

Personally, I would like to see PhilHealth be privatized and/or abolished, but that's not a realistic scenario. A more realistic one is the deregulation and demonopolization of the health insurance sector. Allow private firms or NGOs to compete among themselves in providing healthcare to the people, both in the formal and informal sectors.

In Switzerland, workers can get a health insurance via their labor union, or the company-sponsored one, or through their village and neighborhood association, etc. So people have many choices in getting healthcare that is tailored for them. There is no PhilHealth-like government insurance monopoly where people are mandated and coerced to become members, even if they are not happy with the amount of forced contribution and its service. See here, Healthcare competition 1: Switzerland, August 28, 2010.

Health Transparency 4: Drug Promotions and Government

The Medicines Transparency Alliance (MeTA) - Philippines conducted a series of workshops for various groups and sectors on "Ethical Drugs Promotion and Marketing", August 31 to September 3, at the Asian Institute of Management (AIM) in Makati City. The workshop for civil society groups, consumer and patient groups, was held the other day, September 1, afternoon. Leaders of member-NGOs of the Coalition for Health Advocacy and Transparency (CHAT) like me attended the workshop.

The main resource speaker for all the workshop groups was Ms. Carole Piriou of Health Action International (HAI), a think tank based in Amsterdam. Carole gave a good presentation but I did not agree with some of her analysis and recommendations. We should get a copy of her powerpoint presentation in the coming days, but I took a photo of 2 of her slides.

Here is one of the slides of Carole. Based on some HAI surveys or studies, they say that "newer medicines are not necessarily better" as 69 percent of new (and patented) drugs are "nothing new." This assertion should get the attention and counter-arguments of the innovator pharmaceutical companies because the purpuse of medicine innovation is to develop more disease-killer drugs, or retain the original disease-killing capacity but with the minimum adverse effects. That should be "something new."

Another issue that Carole discussed, was that Continuing Medical Education (CME) via sponsored symposia and conferences by pharma companies for physicians have direct and positive correlations to increased prescription of the drugs produced by the sponsoring company.

I think that point is not surprising. I do not know if there is a neutral or independent body or organization that provides CME to physicians where all new drugs and vaccines from different innovator and generic pharma companies are presented and discussed in terms of their disease-killing capacity, any adverse effects, price, and so on.

In the absence of such independent group, then drug manufacturers will launch their own CME to certain physicians to explain about the properties of their new drugs. This has the indirect effect of active promotion and marketing, of course. If the manufacturers themselves will not do it and there is no independent body that will study and analyze the properties of new drugs coming out from different pharma companies, who will?

Dr. Kenneth Hartigan-Go, a former official of MeTA Philippines, now a professor of health management at the AIM, also gave a short presentation of the kind of promotions and marketing that some pharma companies advertise in media -- radio, tv, newspaper, and so on. The pictures that he showed were indeed very revealing. We hope to get a copy of his presentation in the coming days too.

An important consideration why many pharma companies resort to aggressive advertising and marketing, is because majority of Filipinos do not have outpatient health insurance card/organization. PhilHealth can be used only if one is confined for at least 24 hours. So since people do not have outpatient health insurance cards, they do not see a doctor for their minor diseases (fever, flu, headache, etc.) and get professional advice. People resort to self-medication -- like the drugs what they saw or heard on tv, radio, etc.

The biggest pharma company in the country is United Laboratories or Unilab. Its gross sales in April 2009 for instance, P25.8 billion, was slightly bigger than the combined sales of no. 2 (GSK), no. 3 (Pfizer) and no. 4 (Wyeth). Unilab is also the biggest drug advertiser in the country, its ads are visible in radio, tv, newspaper, billboards, and so on.

So, should government further regulate drug promotions to physicians and the public? My quick answer is No. When there is sufficient competition among various pharma manufacturers, among drugstores and among healthcare providers, that competition is the best regulator in terms of price, product quality, and corporate accountability.

Besides, the Food and Drug Administration (FDA, previously BFAD) has its staff over-burdened already with regulating everything from new (and/or imported) drugs to skin whiteners to fruit juices to processed/manufactured foods, drinks and soda, and so on. So to ask them to create a new set of regulations and monitoring system will simply raise public expectation and later, public disappointment.

Civil society organizations (CSOs) -- NGOs, people's organizations and coops, media, consumer groups, church groups, civic groups, etc. -- bonding into a big coalition can monitor drugs promotion and marketing. Then slam-dunk those firms that exaggerate the properties and healing power of their drugs. This public pressure and consumer vigilance is a more effective regulator than any combined government bureaucracies' regulation.