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.

Drug Innovation 2: Sustaining Innovation via Competition

I noticed today on twitter a number of messages on the annual meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA) Annual Meeting in Boston, so I checked their website, http://phrma.org/.

Saw this photo there, good theme. Medicines, whether innovator or generics, so long as they are the real ones (ie, non-fake, non-substandard) and have passed stringent requirements for safety and efficacy by the drug regulatory agencies, and are regularly monitored via pharmaco-vigilance, should be useful to people and communities.

There should be no debate on the delineation of service and usefulness between innovator drugs and generic drugs because most, if not all, generic manufacturers recognize the high risks and huge costs of inventing new medicines against various diseases -- old, emerging, mutating/evolving new ones. Thus, intellectual property rights (IPR) schemes like patents are generally recognized.

But there are certain sectors and ideological interests, political groups and politician interests, that do not want to respect IPR schemes by which innovator companies abide by existing rules. And various debates and new government regulations that tend to demonize innovator companies while silently praising their newly invented drugs have cropped up.

I believe that patients and public interest will be maximized if we have more, not less, innovator companies around, competing with each other in giving us more powerful treatment and medications. After their new drugs' patent have expired, a new round of competition, more fierce competition in fact, comes in with the entry of many generic manufacturers. And public interest is further advanced with more choices, more options for patients and health professionals.

Anyway, I am posting below four short articles from the PhRMA website that are related to medicine innovation and their Boston meeting, below. Enjoy.
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Opportunities Abound, Say Viehbacher and Lechleiter

by Kate Connors on 4/13/2012

In their moderated discussion this morning, outgoing PhRMA Chairman Christopher Viehbacher (from Sanofi) and incoming PhRMA Chairman John Lechleiter (from Eli Lilly and Company) discussed ways that companies can maximize different types of opportunities.

Of course, in the biopharmaceutical sector, science is key. As Viechbacher said, the promise of the research happening now is built on knowledge we’ve developed in the past: “Most of our success in the 1990s was based on targets that came out of research in the1970s and 1980s. Now we’ve got new targets coming out of NIH and it’s opening up opportunities everywhere. If we can come up with new models, we can capitalize on these opportunities.”

Lechleiter concurred: “There’s a sense in the room today of much more optimism than pessimism. People critical of how much R&D we’ve spent in a last decade with what they call diminished returns are looking in the rear-view mirror. I’m encouraged by the way that large companies, small companies, government and academia can work together.”

He also highlighted the President’s Council of Advisors on Science and Technology, which is working with many PhRMA members as well as other stakeholders, as an opportunity to improve the way that we get medicines to patients.

Both agreed that increased collaboration with patients can also help open doors to both research and access, as well.

As Viehbacher said generally, but significantly: “There are enough opportunities to go around.”

Inspiration for Advancing Medical Innovation

by Christian Clymer on 4/13/2012

This is a guest post from John C. Lechleiter, PhD, who is Chairman, President and CEO of Eli Lilly and Company. Starting today, Mr. Lechleiter is also the Chairman of the Board of Directors of PhRMA.

The biopharmaceutical industry is all about medical innovation. It’s our lifeblood. Yet, too often we talk about medical innovation without making it hit home for people outside the industry.

Rewind to three decades ago, when HIV first became a major public health concern. Not only were we on the verge of a human disaster, but public health officials worried that we wouldn’t have enough hospitals to treat an approaching avalanche of AIDS patients. Thanks to medical innovation, it didn’t happen (AIDS deaths have dropped by 70 percent since 1995). Similarly, thanks to a two-thirds drop in the death rate from coronary heart disease in the U.S. since the 1960s, 1 million more Americans are alive each year. Anti-hypertensive treatments alone account for 800,000 fewer hospitalizations each year – and 86,000 fewer deaths.

These are impressive and important success stories, but our work is far from over. Fast-forward to today: too many people still die from cancer. Diabetes is growing at epidemic rates. And Alzheimer’s disease represents an imminent crisis. The Alzheimer’s Association says that by 2050, more than 13 million Americans will have the disease – at a cost of more than $1 trillion annually – unless better treatments are found.

Sustaining our advances in medical innovation is priority one -- and it’s incumbent upon all those in our industry to make it happen. The ongoing revolution in the life sciences, with all its promise, will mean little without public policies that foster innovation. We have to get our story out in compelling and meaningful ways. Our industry must also continue to build trust with our various stakeholders. By telling the stories of our mothers and brothers and children who’ve been saved by new medical treatments – and by upholding the highest standards of integrity and ethical behavior in everything we do – the fruits of our efforts can be fully realized.

I’m proud to chair PhRMA’s board for the next 12 months – and it’s an honor to be part of an industry that focuses on saving lives. But let’s not look at our past successes as some sort of historical footnote. Let’s use them as inspiration to find new innovative treatments for the next generation of patients. They’re waiting.

What April 12 Means to PhRMA’s Chairman

by Kate Connors on 4/13/2012

New PhRMA Chairman John Lechleiter, President and CEO of Eli Lilly and Company, continued the vein of optimism in his comments this morning. He urged those of us in the room “to stand up for policies that support innovation, to continue to build trust with our stakeholders, and to get our powerful story out.”

We must do so, he said, to continue the “heroic work of healing and saving lives well into the future.”

Yesterday’s date, April 12, is “famous in the annals of innovation.” On that date in 1961, the first human flew in space. Twenty years later to the date was the launch of the space shuttle program. Around the world, these moments in space exploration have been held up as examples of true innovation.

However, Lechleiter said, there is a much more important April 12. On that date in 1955, it was announced that Jonas Salk’s polio vaccine worked: “That vaccine turned a disease that once horrified America into a memory, and over time would do so for most of the world.”

He added: “Medical innovation over the past century transformed the basic expectations of human life that had prevailed since the dawn of civilization.”

Lechleiter continued, discussing the overall value of prescription medicines. And he discussed medical need. And he discussed increases in generic utilization rates.

But after the last day and a half of conversation about innovation, collaboration and development, it feels good to focus on the aspirational, because all of us here in Boston certainly share that optimism: “I believe that the juxtaposition of new insights into human biology, coupled with the application of new tools and advancements in technology, has the potential to revolutionize our business more in the next ten years than in the past 50.”

He closed urging us all to “preserve the innovation that is at the heart of what we do and that people are counting on us for.”

PhRMA Member Companies Invested $49.5 Billion In Research and Development in 2011

2012 Industry Profile and Updated Chart Pack Resource Now Available

Washington, D.C. (April 12, 2012) — Investment in research and development by members of the Pharmaceutical Research and Manufacturers of America remained strong at $49.5 billion in 2011, as the sector adapts to meet the challenges of evolving science, a changing marketplace and a difficult economic environment.

Biopharmaceutical research companies are continuing to explore the possibilities associated with more targeted therapies and personalized medicines, and are building on the benefits associated with partnerships among experts throughout the research ecosystem.

These efforts are reflected in PhRMA’s new 2012 Industry Profile as well as an updated version of its informational chart pack resource, “Biopharmaceuticals in Perspective,” both released today. Both sets of materials are available for public use and are intended to provide  timely, relevant information about the biopharmaceutical research sector, which includes both pharmaceutical and biotechnology companies.

The 2011 R&D investment figures reflect the biopharmaceutical sector’s standing as America’s most research-intensive industry. According to a recent report by the National Science Board of the National Science Foundation, the U.S. biopharmaceutical sector accounts for the single largest share of all U.S. business R&D, representing nearly 20 percent of all domestic R&D funded by U.S. businesses. In the U.S., R&D expenditures among PhRMA members represented a remarkable 21.1 percent of domestic sales....
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See also:
Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials, March 28, 2012
IPR and Medicines 16: Wikileaks and the Cheaper Medicines Law, November 08, 2011

IPR and Medicines 17: Why are Drugs Still Expensive After Patents have Expired? November 17, 2011

IPR and Medicines 23: Profitability of Innovator Pharma Companies, March 16, 2012
IPR and Medicines 24: Balancing Costly Innovation and Cheaper Drugs, March 20, 2012

Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials

To distinguish discussions related to intellectual property rights (IPR) like compulsory licensing, I am starting a new thread in this blog just on "Drug Innovation". This is slightly different from the thread on "IPR and Medicines".

My elder brother who died of prostate cancer more than five years ago would have been 57 years old this week had he survived the disease. His diabetes plus emotional sadness when his wife died several months earlier due to colon cancer further aggravated his condition.

My other relatives, wedding godparents, friends, family members of friends, also died of cancer. There are different types of cancer, probably about 200, and all of them are dangerous. Perhaps all of us have cancer cells in our body, but our immune system are just strong enough to kill those cells, or at least keep them at bay and prevent them from expanding and invading other organs of our body. Our immune system is our best physicians, our best medicines, our best disease examiner, all rolled into one. It is very important therefore, that we keep our immune system strong and efficient, by not injecting too many substances that can weaken them -- like cigarettes, alcohol, fatty food and so on. A little of these substances, like when we attend parties, would be fine and our immune system should be able to repair minor damages. It is the excessive use of such substances that can create more damages in our body.

Medicines and vaccines help boost our immune system in killing undesirable cells like cancer. Usually, old medicines are less efficient in doing this job as human understanding of each disease improve through time. Thus drug innovation is a must. Diseases mutate and evolve, so treatment against such diseases must also evolve.

The business of medicine innovation should be depoliticized whenever possible. There are existing rules governing patent, trademark, copyright and other IPRs, all players, innovator and generic manufacturers especially, understand those rules and do their respective business plans and marketing that are compliant with those rules. That is why I question and oppose moves or proposals that governments should issue compulsory licensing (CL) and related political schemes that disrespect private property rights.

What governments should do, is encourage the entry if not proliferation, of more innovator companies. If there  will be 20 or 50 different innovator companies that develop and roll out new medicines (on top of existing, off-patent drugs) per disease, then the patients will greatly benefit. Competition among such innovator companies will bring down prices of such innovator drugs. Then another round of competition will follow once the patent expires as dozens if not hundreds of generic producers come in to produce their own branded drugs for each disease category.

I am posting below three articles by Reiner Gloor in BusinessWorld on dates indicated. Reiner is the Executive Director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), the federation of mostly innovator pharma companies in the country. The three papers are:
1. Beating Cancer,
2. It all begins in innovation, and
3. The value of clinical trials.

The subject of bioequivalence and related tests for safety and efficacy of generic drugs before they will be introduced to the public are discussed. These are useful information that need to be shared to the public.

The most expensive drugs are those that do not work and hence, do not kill a particular disease, no matter how cheap they are. Because an ailing patient would have more complications as the disease inside his.her body is not treated and allowed to expand and inflict more damage in other internal organs of the patient.
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(1) http://www.bworldonline.com/weekender/content.php?id=46080

Posted on 06:05 PM, February 02, 2012

Medicine Cabinet -- By Reiner W. Gloor

Beating cancer

Major non-communicable diseases were among the important health issues that gained the attention of world leaders in 2010. In a United Nations summit, political leaders agreed to a plan of action that sought to address alarming trends involving four major non-communicable diseases (NCD) that have developed to become the world’s biggest killers.

The four major NCDs are cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers that have altogether prematurely claimed the lives of 38 million people, representing about 63% of the total global deaths in 2008. Studies indicate that the major NCDs are affecting the developing world and lower-income populations hardest.

This is particularly true for cancer, which accounted for about 7.6 million global deaths in 2008. By 2030, cancer deaths are also expected to soar to 11 million worldwide. The World Health Organization (WHO) also disclosed that about 70% of all cancer deaths occur in low- and middle-income countries.

Cancer can affect any part of the body. A defining feature of cancer is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and spread to other organs. This process is referred to as metastasis which is the major cause of death from cancer, the WHO said.

Locally, the Department of Health recently led the observance of the National Cancer Awareness Week in a campaign to boost public consciousness on the disease. Such an awareness drive is important specifically for the Philippine Society of Medical Oncology (PSMO), which considers information as a keystone to preventing and treating cancer.

The need to raise awareness on cancer has become more evident with the GLOBOCAN Project report, which estimated that there had been more than 51,000 cancer deaths in the Philippines in 2010.

The GLOBOCAN Project, which provides global incidence of, mortality and prevalence from major types of cancer, reported that leading new cancer deaths among Filipinos in 2010 include those involving the lung, liver, breast, colon/rectum, leukemia stomach, cervix uteri, brain, prostate and pharynx.

Among Filipino men, lung and liver cancer comprise 43% of all new cancer deaths. These top two killer cancers affected more than 12,000 Filipino men.

On the other hand, breast cancer was the number one cause of new cancer deaths among Filipino women also in 2010. It is estimated that more than 4,000 Filipino women died of breast cancer or 18% of all total deaths during the same year. Around 2,197 women and 1,984 others succumbed to lung and cervical cancers, respectively.

Breast cancer also topped the list of new cancer cases in 2010 followed by lung, liver, colon/rectum, cervix, leukemia, stomach, prostate, brain and ovarian cancer. The top 10 leading sites comprise 68% of all new cases.

Despite the threats posed by cancer, the disease can be reduced and controlled by implementing strategies for prevention, early detection and care for patients with cancer. These include modifying key behavioral and dietary risk factors as well as early detection and screening tests which are important in the diagnosis and treatment before cancer becomes advanced. Vaccination against human papilloma virus (HPV) and hepatitis B virus also help in cancer prevention.

PSMO President Dr. Felycette Gay Martinez-Lapus explained that the fight against cancer requires a collaborative effort among the physician or physicians, the patient, the patient’s family and friends.

She added that treating cancer is a delicate balancing process. The general aim is to reduce tumor growth while ensuring that any potential side effects do not compromise the patient’s quality of life to the extent that the treatment does more harm than good.

Dr. Martinez-Lapus acknowledged that in recent years, there has been a surge of innovative drugs which has forever changed the landscape of cancer treatment.

She said that as opposed to about 40 years ago, life expectancy have increased with new medicines that target the cancer cells directly. Today, targeted therapy is more precise in that it is formulated to act against a specific type of cancer unlike previous treatments.

At the moment, researchers are working on more than 800 innovative medicines that are either undergoing clinical trials or regulatory review. Due to these developments, cancer can now be better managed and even beaten.

Generic Drugs Philippines 2: 24 Years of Generics Act

Generic drugs are those medicines not covered by the patent protection and which are labelled solely by their international non-proprietary or generic name. That's the official definition in The Generics Act of 1988. Wiki also defines it as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use... A generic drug must contain the same active ingredients as the original formulation."

The Generics Act will turn 24 years old this coming mid-September. And the drug price control policy will also turn 3 years and 1 month old that time.

A local health coalition, the Ayos na Gamot sa Abot Kayang Presyo (AGAP), or Good Medicines at Good Price, http://ayosnagamot.wordpress.com/, in partnership with several organizations, will sponsor a talk by the DOH Secretary when the law was enacted, Dr. Alfredo "Alran" Bengzon next week. I was among those invited through our bigger health association, the Coalition for Health Advocacy and Transparency (CHAT), I will come.

The law has five goals why it was enacted:

To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs;

To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavour to make them available free for indigent patients;

To encourage the extensive use of drugs with generic names through a national system of procurement and distribution;

To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognisant of the therapeutic effectiveness; and

To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions.

I think these are good and clear objectives. It is clear that the law would not be looking at branded generics as purely "generics" because the latter emphasizes the scientific name of the drug molecule, not its commercial brand identify, even if the latter is manufactured by a pharmaceutical company, domestic or multinational, that produces 100 percent generic drugs.

As explained to me by Lyle Morrell of Watsons and Joey Ochave of Unilab on two separate occasions, the "generics" as contained in the Generics Act of 1988 refer only to "generic-generics". There are two other type of generics in the local market: (a) product-branded generics (Examples: Tempra, Alaxan FR, Biogesic, Solmux, Tuseran, etc.) and (b) company-branded generics (Ritemed, Unilab ba yan, Pharex, etc.).

Thus, the latter two would not be considered as "generic-generics" which again, is the main advocacy of that law. This may sound like discussion on semantics but it maybe important to clarify these things as certain sectors and players in the local health sector are confused and may not be aware of this distinction and their implications when it comes to strictly implementing that law.

Doc Alran has a wide experience in health policy, both public and private healthcare. He was DOH Secretary from March 1986 to January 1992, see the DOH's brief description of his term here. After his term as DOH Secretary in the late 80s, and a short stint as a Peace Negotiator, I think he never went back to the public sector. He is now the Dean of the Ateneo School of Medicine and President/CEO of Medical City. He has lots of insights as a private health practitioner and manager.

I wrote here one time, that he talked at one of the meetings of the DOH Advisory Council on Price Regulation more than two years ago, saying that drug price control policy is wrong. In their case at Medical City, he said that they are in the business of healthcare, to make sick people get well and go home, they are not in the business of drug retailing. By forcing prices of certain drugs to go down at a level that does not reflect the cost of dispensation, monitoring, replacing, monitoring, etc., their bottomline as a healthcare provider is adversely affected. He called the drug price control policy as a short-sighted, quick-fix solution that creates more problems than it solves and thus, requested that the policy be withrawn, or at least the policy should not apply in hospital pharmacies.

It seems that then DOH Sec. Francisco Duque ("DOH-K" was the slogan of the DOH in his term) was more of a politician than a healthcare professional. Advice like that, as well as the voices and representatives of the different sectors who are members of the Advisory Council -- local pharma, multinational pharma, drugstores, hospitals, physicians, pharmacists, consumer groups (like us) -- did not get into his ear. Then DOH USec Alex Padilla and NCPAM Director, Doc Robert So were there in that meeting. USec Padilla I think was not convinced of drug price control policy, but his boss, Sec. Duque, and their higher boss, then President Gloria Arroyo, wanted that policy for additional populism, he has no option but obey his bosses.

It would be interesting to hear what former Sec. Bengzon would say about the Generics Act, 24 years after it was passed. The event is free but it is by invitation only. For those interested, you may call and write AGAP.
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See also:
Generic Drugs Philippines 1: Generics Summit, September 2011, February 09, 2012
IPR and Medicines 18: Generic Drugs and the Consumers, November 18, 2011

Generic Drugs Philippines 1: Generics Summit, September 2011

I am starting a new thread in this blog, the "Generic Drugs Philippines" to differentiate it from "Generic Drugs Asia". The latter will focus on development in the generics industry in the continent, while the former will focus on the Philippines. The paper below, I have already posted as IPR and medicines 12: Expanding generics, September 09, 2011, and  IPR and medicines 13: Improving Generics Quality, September 13, 2011. But I removed many photos, retained only 2 and the texts. You can check the photos in the above links.
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2nd Generics Summit, September 7-9, 2011

I attended the 2nd Generics Summit organized by the Department of Health (DOH) and one of DOH's big office, NCPAM. It was held the past two days, September 7-8, at the Richmonde Hotel in Eastwood, Libis, Quezon City. 

Day 1 morning session was about welcome messages from top officials of key players in the generics industry in the country -- DOH Secretary Enrique Ona, FDA Director Suzette Lazo, WHO Philippine Office Soe Nyunt-U, PCPI Beau Agana, and PHAP Eufe Tantia (in behalf of Reiner Gloor who followed later). Then generics exhibit at the Eastwood Mall.

Then a generics expo exhibit was formally opened late morning that day, at the 2nd floor of the Eastwood Mall. I had the chance to have a photo with Beau Agana, President of the Philippine Chamber of Pharmaceutical Industry (PCPI) and CEO of Pharex Pharma, and Reiner Gloor, President of the Pharmaceutical and Healthcare Association of the Philippines (PHAP). PCPI is composed of mostly if not entirely Filipino companies (manufacturers, drugstores, more than 120 member-companies) while PHAP is composed of mostly multinational and innovator pharma manufacturers, also some local drugstores). 

Afternoon session was packed with many discussions and some debates. First session was on Improved Healthcare Access and the four speakers were:
1. Oscar Picazo of PIDS who spoke about access to cheaper medicines via the Botika ng Barangay (BnB), Botika ng Bayan (BNB), DOH treatment pack and other programs.
2. Ruth Natividad of IMS Health who spoke on impact of the Cheaper Medicines Law with their survey of both physicians and patients, their knowledge of the drug price control policy and related provisions,
3. Romeo "Al" Castro also of IMS Health who spoke on the overall generics picture in the country, and
4. Catherina Timmermans, Technical Director of WHO, spoke on the global picture of generics. 

Here's one twist. I went to the Summit as an ordinary participant, not a speaker nor a reactor. While the last speaker, Ms. Timmermans, was delivering her talk, I was asked by a friend at the DOH if I can be one of the reactors as two scheduled reactors from the consumers and civil society were not around.

Perhaps being used to spontaneous writing and thinking as a blogger, I said YES, even if I have just about 10 minutes to compose my thoughts, write comments and draft questions, to the four speakers. Tough job eh.

In those roughly 10 minutes (or less) from the time I was informed to be an instant reactor to the time I went to the reactors' table, this is what I said.

I speak here as a consumer and as a taxpayer. As consumers, our interest is simple: more choices, more options, from more competition among more players, from innovator and generic manufacturers, from more drugstores. Getting subsidies is not much a major concern.

Thus, government policies that inhibit if not kill competition among players, like the drug price control policy, is wrong and against our interest.

As taxpayers, it is unfair for us if we pay plenty of taxes so that government will have more money to subsidize those who over-drink, over-smoke, over-eat, over-sit, over-fight, over-sex, and when they have frequent stab wounds, have AIDS, have fat bodies, etc.

Now to my questions.

For Mr. Picazo of PIDS, you know the bad fiscal situation of the government, the high annual budget deficit, the high public debt burden and the high interest payment to pay for those public debt. Consider for instance, interest payment alone, principal amortization not included yet, of the national government: P294 B in 2010, P357 B this year, and P333 B in 2012. Would you recommend that government should limit, if not get out of the Botika ng Barangay (BnB) since many of them are not performing well financially, in order not to further bloat the spending and the public debt? There are many private generic drugstores now that are entering more and more small municipalities and even poor barangays, like The Generics Pharmacy, independent and non-chain drugstores.

For Ms. Natividad and Al Castro, since IMS data show that the current drug price control policy did not achieve its main goal, and IMS data are for subscribers only and its rather expensive to get subscription, would you be wiling to show your data to Congress, especially on the deliberation of Cong. Biron's bill to expand the price control and an idiotic and wrong policy of creating a new government bureaucracy called the Drug Price Regulations Board?

For the WHO, while promoting generic drugs which is a good policy, but aren't you spearheading some anti-innovation and IPR-busting policies like compulsory licensing, early working, parallel importation?

Their reply were, as far as I can remember them, as follows:

1. Picazo: Yes, the fiscal burden is big, so I recommend that for those BnBs that are going under, they should be allowed to close and not be subsidized further. 

2. Castro: Yes, we are willing to show our data if it will help promote good public health. Provided also that we will not be cited for contempt or be harassed.

3. Timmermans: No, we are not advocating IPR-busting policies, it's just that some policies to enable governments to deal with health emergencies should be on hand.

After the panel speakers and reactors went to their seats, I was approached by some friends and other participants in the audience, saying that they liked my reaction, yeah! One of those who approached me was the President of The Generics Pharmacy. I think people appreciate it when I emphasize the personal responsibility aspect of healthcare, it's not all about government responsibility, or pharma manufacturers and drugstores responsibility.

The next panel that afternoon was on Private Sector Efforts in Improving Access to Generic Medicines. The speakers were the respective heads of Reiner of PHAP, Beau of PCPI, and the Philippine Medical Association (PMA), Dr. Oscar Tinio.

This is one slide shown by Reiner. I think this will help people realize the role of drug innovation, that without innovator drugs, there will be no generic drugs. Or without innovator companies, there will be no generic companies. Thus, continued efforts, explicit or implicit, to bust the patent and IPR system, will have both short- and long-term negative impact on drug innovation.

And here is one of the many slides that Beau showed, showing an important point that even prior to the drug price control policy of the government, the average price of drugs for co-amoxiclav molecule (anti-biotics, anti-infection), simvastatin (anti-high cholesterol), amlodipine, and other important molecules, have been going down. 

What the drug price control policy has done is to force, to coerce, further price reduction of the innovator drugs, but several generic drugs were also eased out of the market as they have little leeway for major price reduction. Beau said he will send me his presentation, so I can write more about the subject.

The next panel was on the Retail Landscape and Intellectual Property Landscape. The speakers were Janet Estranero of The Generics Pharmacy, Epifanio Evasco of the Bureau of Patents, Intellectual Property Office (IPO), and Catherina Timmermans of WHO. I would have wanted to be a reactor in this panel as IPR and medicines is among my favorite topics. But the reactors that afternoon were also great minds, like FDA Director Suzette Lazo, from the Philippine Pharmacists Association (PPhA), others.

Mr. Evasco said that while compulsory licensing (CL) is clearly in the Cheaper Medicines Law, they have not accepted any CL application yet from any of the local pharma companies. They received one CL application in 1998, and there was no successor application then. 

I think this is good. All the big and blockbuster drugs like amlodipine, clopidogrel and atorvastatine already lost their patents. There are now plenty of branded generic drugs on these molecules sold at much lower price than the innovator brands, so consumers and patients have more choices now. There are a few remaining patented drugs in the Philippine market but these are not blockbuster drugs, like anti _____ cancer. Any CL applicant will spend huge money anyway in legal battles, so why spend big on lawyers and PR guys when you can spend your money developing and marketing new and more branded generics of the blockbuster off-patent drugs. Or wait for those patents to expire in a few years and spend your savings and resources developing new generic drugs.

The WHO recently is going almost full throttle on the campaign to control non-communic-able diseases (NCDs) or lifestyle-related diseases. The infectious diseases are now generally under control except for some disease outbreaks like SARS and H1N1. 

My position on the matter is simple: If people will over-drink (have liver cancer, intestinal disorder, etc.), over-smoke (have lung cancer, throat cancer, etc.), over-eat and over-sit (have hypertension, high cholesterol, diabetes, etc.), is it other taxpayers' problem via governments and the WHO? Self-inflicted diseases should be addressed by self-financed healthcare, with assistance from friends, family, private and charity foundations. Government assistance and subsidy may be expected -- no one can stop now those politicians and legislators if they will coerce getting more of our money via more and high taxes to spend on things that whet their political appetites -- but this should be limited.

Day 2 of the conference, morning panel was on "Higher Levels of Quality". The presenters were Dr. Suzette Lazo, FDA Director, she spoke on the Food and Drugs Strengthening Act (RA 9711). The other speaker was Jesusa Joyce Cirunay, Chief of FDA Regulations Division, who talked on two related topics, (a) ASEAN Harmonization and ASEAN Economic Community by 2015, and (b) Pharmaceutical Product Working Group (PPWG) and Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Now there's another twist in this panel. The civil society reactor for this panel was not prepared to talk, my friend from DOH again asked me if I can replace him. I had second thought because I came late and I did not hear Doc Suzette Lazo's presentation. Later I said Yes. Again, with just 5-10 minutes to prepare, I jot down my thoughts and made these comments as a panel reactor.

I have one comment then one question. On harmonization: companies and consumers benefit from product differentiation, competition and market segmentation, to recognize different consumers with different needs and different budget. When you harmonize, you tend to standardize, go for uniformity, even monotony.

The ASEAN harmonization is partly patterned from EU harmonization. EU harmonization is to a certain extent a regional EU protectionism. When the newly market economies of Eastern Europe (Czech, Latvia, etc.) that joined the EU introduced low income taxes, both corporate and individual income taxes, it created tax competition within the EU as the big EU countries like Germany, France, UK, have high income taxes. Some companies there moved out and went to the low-taxes EU members. The bureaucrats in the high taxes countries were not happy with this, so they introduced tax harmonization. I am not saying that harmonization per se is bad since one goal of harmonization is to have one general standard of regulations, but there are features of harmonization that are not in favor of consumers as it tends to reduce competition and differentiation.

Now to my question: Isn't ASEAN harmonization a form of regional protectionism? Say pharma products from Indonesia, Malaysia, Singapore, etc. can easily go in and out within ASEAN, but pharma products from India, China, Pakistan, etc. which are said to be the sources of cheaper medicines, will have a harder time coming in?

Doc Suzette Lazo replied that it's not their field to answer the question, that perhaps economists like me can better answer that question. Ms. Cirunay replied that if there are trade disputes like protectionism, there is the WTO that country governments can go to file a complaint.

I was satisfied with their brief answers, I did not make a follow up questions anymore. After the panel break and snacks, Doc Suzette called me to her table and kidded me, "Noy, ang hirap naman sagutin ng tanong mo, pang-econ yon eh", to which I laughingly replied, "Kasi Doc, naisip ko lang, baka may ilang vested pharma companies within ASEAN who want to reduce competition from Indian pharma or Chinese pharma."

The next activity was the awarding of certificate of Good Manufacturing Practices (cGMP) to several local pharma companies. This is a good move to encourage better, world-class generics manufacturing standards.

The afternoon session was on "Rational Use of Medicines". The program director of DOH-NCPAM, Dr. Melissa Guerrero, presented the Philippine Medicines Policy 2011-2016. Then four speakers followed her. (a) Dr. Isidro Sia, Chairman of the Formulary Executive Council (FEC) presented the Philippine National Drug Formulary.

(b) Dr. Armando Crisostomo of UP College of Medicine talked about Anti-Microbial Resistance (AMR)-Global Strategies; (c) Ms. Catherine Dauphine of WHO talked about the Regulation of Pharmaceutical Promotion in the Philippines; and (d) Mr. Lyle Morrell of Watsons Pharmacy talked about Industry Initiatives & Compliance to Rational Use of Medicines.

I liked Dr. Crisostomo's presentation. AMR kills by tens of thousands worldwide as old diseases can easily evolve or mutate into new diseases. He said something like 440,000 new cases of MDR (microbial disease resistance) annually. That's a rather scary number. He mentioned about the need for new drug innovation to battle those mutating diseases. I notice that in his presentation though, he quoted several times WHO Director-General Margaret Chan, that I felt like his paper was partly a WHO presentation.

Mr. Morrell mentioned about the threat of the Superbug -- the antibiotic resistant bacteria -- and the need for patients' compliance of their medication. He has two important advice to patients: (a) Do not self-medicate, and (b) complete your antibiotic prescription. He also shared the frustration of some Watson's pharmacists, that antibiotics are prescription drugs, not over the counter (OTC) drugs. A number of their pharmacists are berated by some customers who insist that they can buy any antibiotics even without prescription from physicians. Tough job, Lyle.

The last activity of the two-days event was the signing by key players and stakeholders of the Philippine Medicines Policy.

Sometimes I could be not-so-kind with the DOH in my past writings especially on the drug price control policy. But the DOH deserves kind words and appreciation for holding such a successful event where the proper roles of drug innovation and generic drugs were highlighted.

Some photos of the Generics Exhibit at the Eastwood Mall, just one floor below the conference venue. The local generics industry is showing constant improvement in both product quality and marketing sophistication.

Nonetheless, the public should realize that without drug innovation, without new molecules discovered by the innovator companies, there will be no generic drugs.

During coffee breaks, the subject of deaths from dengue would crop up from our informal talks. This mosquito-transmitted infectious disease is killing both rich and poor, within days and sometimes, within hours, if not properly diagnosed and controlled. There is one recent case of the child of the country director of one multinational pharma in the Philippines, a teenager who died of dengue.

The bad news is that currently, there is no vaccine yet against dengue worldwide. The good news is that a vaccine would be coming in 2 to 3 years from at least two innovator companies. Some sectors though would insist, "Aha, new vaccine, patented and hence, expensive. Government should issue a compulsory license or exhaustion of rights (ie, parallel importation) policy since that drug responds to a health emergency for many areas in the country."

I say that it is not a good way to treat drug innovation. To treat the inventors of modern and more revolutionary drugs as profit-hungry wolves is not only unfair, but it invites new government intervention based on envy. There is a place under the Sun for both innovator drugs and generic drugs. What is "new" and innovator drugs today will be "old" and generic drugs tomorrow.