Generic Drugs Asia 2: My presentation at CGDA 2011

Posting my presentation here during the CGDA 2011 in Taiwan, including my adlibs during the talk. Many of these slides and images can be found in my previous articles here....
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Being the 3rd to the last speaker in a two days full conference has the advantage because people are rather tired and would want to see and hear the presentations quick. So instead of 30 minutes alloted to us, I will speak for only 15 minutes as much as possible, so you have to read fast as I will speak fast :-)

During the welcome dinner last Friday, some fellow people there including fellow speakers asked me if we are a government think tank. So I added these (3rd and 4th) slides).

(5th slide) Consumer interest is more options, period. Whether the price is lower or higher, the quality is shiny or not, let the consumers choose. In a competitive market, consumers can choose whether they want to buy at equilibrium point A or B or C or ... Z. Under a price controlled market, prices at the upper level are abolished and hence, consumer choices are reduced, limited to only those within or below the price set by the government. And this is wrong.

(Slide 8) The good news is that life expectancy around the world is rising, up to 80s in many rich countries like Japan, UK, etc. The bad news is that about two-third (2/3) of all deaths around the world on average are from non-communicable diseases (NCDs): cardiovascular, cancer, respiratory, diabetes, other NCDs. One lesson here is that oftentimes, there is high focus on curative healthcare and people neglect preventive healthcare.

(Slide 10) The implications for this data of declining AIDS death are: (1) medications and treatment are somehow working, (2) previous estimates and projections of death from AIDS were exaggerated, and (3) people are more careful these days to avoid getting AIDS.

(Slides 11 and 12) The same pattern of high incidence of death from NCDs is also observed in the Philippines. Data from the National Statistics Office (NSO) and the Department of Health (DOH).

(Slide 13) The photos and images here are real, some are just for fun, but they illustrate the causes of many self-inflicted diseases -- heavy drinking, smoking and eating.

We now go to Drug Price Control policy and the generics...

Prices of both innovator and branded generics have been declining even before the policy was imposed due to increasing competition.

(Slide 21) Data is from Watsons Pharmacy and it reflects the move towards the innovator drugs by the ABC class, the main customers of Watsons.

(Slides 22 and 23) These charts are from the Pharmaceutical and Healthcare Association of the Philippines (PHAP) and they illustrate the high costs of R&D, the high failure rate, in drug innovation. And of the 20 years total patent period, actual commercial period is only about 11 1/2 years. Which shows the need for IPR protection.

(Slide 24) Research against cancer is high, and this is good. My brother, his wife, my uncle, two of our wedding godmothers, have all died of cancer. It is a messy and costly disease.

These are news reports about the future promises of drug innovation: vaccine against malaria, patent sharing to kill AIDS... news drugs against viral infection, augmenting our immune system to identify and kill cancer cells.

(Slide 27) This is related to the presentation by Mr. Ramana of Dr. Reddy's this morning. That Indian pharma companies are moving into the advance research and possibly innovator field.

(Slides 28 and 29) The shortage of critical medicines like anti-infection and anti-cancer were reported in the US, also in Canada. New cancer cases are now estimated at 12 million per year.

Here now are my concluding notes...

(Slide 35) Joey Ochave warned me of such press releases, that this and that new drug can treat dengue and other diseases. Nonetheless, if such vaccines are made available to the public, even at initial high prices, still people have the option of getting them or ignoring them and stick to standard preventive measures like having a clean environment.

My references are here. I'm done, thank you.

(I missed my self-imposed target of 15 minutes talk only because our moderator, Joseph Wang, the President-Elect of FAPA, smilingly told me that I spoke for 20 minutes. Nonetheless, I gave the audience and fellow speakers 10 minutes of extra rest for the coffee break :-))

Generic Drugs Asia 1: CGDA Notes 1

I am starting a new discussion series in this blog, "Generic Drugs Asia". Mainly about the Conference of Generic Dtugs in Asia (CGDA), November 19-21, held in Taipei, Taiwan. There were so many information imparted over the past two days, I should write about them little by little.

Below is my article yesterday while I was still in the hotel in Taipei. It is posted today in the online magazine,
http://www.thelobbyist.biz/perspectives/less-gorvernment/1239-generic-drugs-and-the-consumers-part-2
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Taipei – Generic drugs have a wide range of use and acceptance in many Asian countries, from as low as 23 percent of total pharmaceutical market volume in Japan to about 65 percent in the Philippines to as high as 80 percent in India. This reflects the extent of confidence or suspicion of generic drugs in our continent.

This is among the important data and information that were discussed during the 1st Conference of Generic Drugs in Asia (CGDA), November 19-21, held here in the capital city of Taiwan. The event was jointly organized by the Federation of Asian Pharmaceutical Associations (FAPA) and the Pharmaceutical Society of Taiwan. The word “pharmaceutical” here also would refer to pharmacists association, and not the pharmaceutical companies.

There were four of us from the Philippines who came to the conference. Ms. Leonila Ocampo, President of the Philippine Pharmacists Association (PPhA) where the association is a member of FAPA; Ms. Nazarita Tacandong,Deputy Director of the Food and Drug Administration (FDA), Jose Maria “Joey” Ochave, SVP of United laboratories (Unilab), and me We were all speakers on different panels.

The conference has four main themes or panels. (1) generics, scientific and legal standing points, (2) government policies for generics, (3) development and contribution of generics, and (4) generics , the perspectives of healthcare providers and patients/consumers. I spoke on the last panel to discuss the view of consumers, not only of generic drugs but also of innovator drugs and healthcare system in general. See my notes about the conference before coming here, also Part 1 of this discussion, Generic Drugs and the Consumers.

In panel 1, the key presentation was made by Dr. Vinod Shah, a senior research scientist at the US FDA. He worked for that agency for the past 30 years, so he really knew a lot about the various requirements and approval process of generic drugs in the US, which has among the most strict regulations worldwide. Dr. Shah said there are 6 strict criteria of generic drugs approval in the US. They must (a) contain the same active ingredient as the innovator product, the inactive ingredients may vary, (b) be identical in strength, dosage form, and route of administration as the innovator drug, (c) have the same use indications (labeling), (d) be bioequivalent, (e) meet the same batch requirements for identity, strength, purity and quality, and (f) be manufactured under the same strict standards of FDA’s good manufacturing practices (GMP) required for innovator products.

Six strict requirements, wow. We wonder if all or most of them are also done in the Philippines and other Asian countries. For many Asian governments, two criteria are set as the minimum: generic drugs must pass bioequivalence (BE) tests and they must get a certificate of GMP from the FDA. Then they add a 3rd or more criteria.

Panel 2 was the presentation of the FDAs of the governments of Malaysia, Philippines, Japan, Korea and Taiwan. Ms. Tacandong of the Philippines spoke about the Generics Law of 1988 including the registration of generic products, the National Medicines Policy, generic labeling, prescribing and dispensing.

Panel 3 has lots of good speakers from among the biggest generic producers in Asia – from Japan, Korea, Philippines, India and Taiwan. Mr. MV Ramana from Dr. Reddy’s, the world’s 12th biggest generic manufacturers, spoke for India. For the Philippines, Joey Ochave of Unilab, the 17th biggest generic producer in the world, spoke. Joey talked about the Philippine pharma market (80 percent of total generics market, and 23 percent of total value including innovator drugs held by Unilab), an assessment of the Generics Act of 1988, the WTO TRIPS flexibilities on intellectual property rights (IPR) on medicines, the Philippine’s intellectual property code (IPC), the Cheaper Medicines Law (RA 9502) and how drug price control policy was inserted into the law when it was not there in the previous bills. Joey was the usual articulate and clear speaker. Even if I know a number of the topics that he discussed, I still learn many new things and insights as I listen to him.

In panel 4, the main presentation was made by Dr. Leslie Benet of the Department of Bioengineering and Therapeutic Sciences, School of Pharmacy and Medicine, University of California in San Francisco. The guy is a big name in the international pharmacy research, he is also a tall guy with a big voice that he needed no microphone to speak even in an auditorium. His bottom line presentation is this: “No prospective study has ever found that an FDA approved generic product does not show the same clinical efficacy and safety as the innovator product, even when special populations (eg elderly, women, severely sick patients) are studied.”

His conclusion would be consistent with the presentation by Dr. Shah of the US FDA the day before as Dr. Shah showed how stringent, how strict, the FDA is in approving any generic drugs to be sold in any drugstore in the US.

For my part, I spoke on “Generics, Perspective from Consumers”. My six-point conclusions were: (a) consumer interest is more choices and options for each molecule or generic category, (b) reduce or remove taxes on medicines and withraw drug price control policy, (c) government should focus its resources on fighting substandard and fake drugs, (d) expanding generics only retailers (GORs) improve access of patients to generic products, (e) drug innovation + generics complement each other in protecting the public, and (f) on drug switching, physicians and pharmacists should guide patients.

I would say that the conference was highly successful as there were lots of information and observations discussed, lots of networking opportunities, all the speakers came, and there was a good audience. The conference venue was also very nice, there is a microphone every two seats so that participants in the audience who want to ask questions need not stand up and go to the microphone in the aisles.

The organizers also arranged three dinner banquet for us speakers, moderators, organizers and sponsors of the conference. So many nice food and drinks, while exchanging notes and information beyond the plenary and conference hall. I thank again FAPA and the Pharmaceutical Society of Taiwan for organizing that first conference on the subject in Asia. It will become an annual conference around Asia in the future, and healthcare providers, regulators, professionals and consumers/patients will learn a lot from such important event.

Taiwan Infra

My first time to set foot on Taiwan, and the first structure that one will see up close is the international airport. It's big, definitely bigger than the Manila airport, but I don't think it is as big as Singapore's Changi or Hong Kong's Chek Lap Kok, or Seoul Incheon's, or Tokyo Narita airports.

The upper photo I took myself on the way to immigration and the exit. Lower photo I got from the web. This should be the view before the departure lounge, I will see this on my flight back to Manila on Tuesday.

What impressed me was the good road infrastructure they have, like many other developed Asian economies like the countries I mentioned above. Malaysia too has good road infra, I was there last month.

Here they are building a two-level skyway, this is the road from the airport to Taipei. Huge and long structures.

I don't know if this is government-built or private sector-led tollway project, but definitely they are huge. If the former, then the Taiwan government is doing a good job in anticipating more land traffic in the future. If it is a private sector project, then it shows their deep pockets to undertake this kind of project.

Here are portions of the semi-finished skyway. Once finished, it should be like a one-way, race track type of road with zero threat of oncoming vehicles on the other side.

More photos of their skyways under construction between Taipei and the Tao Yuan international airport. There is another airport within Taipei but it's a smaller one, mainly for domestic flights, a few international flights like Tokyo.

I arrived at my hotel yesterday afternoon. Then we were treated to a sumptuous dinner by the conference co-sponsor, the Pharmaceutical Society of Taiwan. It was a 15 to 20 course meal, I think. It bordered between high hospitality and gluttony due to the big number of food served in our table.

Some of the last servings. They came in bigger bowls. The only consolation is that they did not serve rice anymore. There simply was no more space in our tummy with all those food. 

I kidded two guys beside me, both from generic drug manufacturers, that perhaps someday, some of them should produce a drug that hastens or quickens the food digestion system. So that what you eat by 6:30 or 7pm will be digested by around 8:30pm, so your tummy will have more space for food that are still coming by 9pm. If ever this drug is invented, it should be a hit in countries where there is high percentage of fat and obese people. They both laughed.

The "Asia Generics Conference" will officially start today. Last night was just an unofficial dinner-networking among the conference organizers, sponsors and speakers.
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See also Migration and Freedom 12: Visa-free entry in Asia for some photos of Taiwan.

IPR and Medicines 18: Generic Drugs and the Consumers

Here in Taipei, my first time to set foot in Taiwan. Arrived at my hotel this afternoon, and the two days conference plus half day closed door meeting will start tomorrow. Below is my article today in the online magazine, an intro about the conference here.
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http://www.thelobbyist.biz/perspectives/less-gorvernment/1236-generic-drugs-and-the-consumers

Generic drugs are those products that are of comparable quality and efficacy to branded or innovator drugs, and are marketed by their generic and molecule names, not brand names.

Drugs usually start from innovator products developed by the innovator and research pharmaceutical companies and are patented. Once the patent expires, the molecule enters the public domain and any generic manufacturer/s can produce their own products provided they pass the various tests given by the government Food and Drugs Administration (FDA) or related bodies. Consumers and patients benefit from more drugs from various generic manufacturers, which has the direct impact of reduced prices due to competition among them.

This coming November 19-21, 2011, the Pharmaceu-tical Society of Taiwan and the Federation of Asian Pharmaceu-tical Associations (FAPA) will jointly sponsor the Asia Generics Conference to be held in Taipei, Taiwan. It is a big conference with participants from many Asian countries, mostly pharmacists, government drug regulators, generic manufacturers and the public or consumer groups.

I was invited to be one of the panel speakers on “Generics: The Perspective of Healthcare Providers and Patients”. I was referred to the organizers by the President of the Philippine Pharmacists Association (PPhA), Ms. Leonila Ocampo, who is a friend and loves reading my articles on Philippine drug policy and other health issues. Thanks again Leonie for such referral.

There are five other speakers in our panel: Generics - Scientist’s Perspective by Prof. Leslie Benet of the University of California School of Pharmacy, USA; Doctor’s Perspective by Dr. Chia-Jui Su of Min-Sheng General Hospital, Taiwan; Pharmacist’s Perspective by Mr. Shinichi Yamamura of Japan Pharmaceutical Association; Public’s Perspective by Ms. Eva His-Hua Teng of Taiwan Psycho-Social Rehabilitation, and Mr. Ivan Li-En Liu of Yeschain Pharma Group.

The main interest of consumers and the public is more choices. Whether they are buying clothes, food, shoes, cell phones or medicines, it is to their benefit if they can find more choices and options among the various products and brands on the same category of goods and services.

Thus, in my presentation, I will focus on government policies that expand the consumers’ choices and criticize policies that tend to reduce such choices. In the case of generic drugs, one Philippine government policy in favor of it was the Generics Law of 1988 where providing the generic name of the drugs prescribed by physicians was made mandatory. Many generic manufacturers were encouraged by this policy and so they developed their own brands on certain molecular values.

One policy though that worked against the generics, was the drug price control policy of 2009. Popular drugs by multinational innovator companies were slapped with the policy, forcing their prices to be 50 percent cheaper, resulting in the shift back to the branded innovator drugs for many patients.

But more than cheaper generics, the public and the patients also have special interest to get new drugs against diseases which have no existing medication and vaccines yet, like dengue and various types of cancer. Or more powerful and more disease-killer drugs compared to existing ones, whether patented or off-patent. Hence, the public would be interested to get those innovator drugs even if they may be sold high initially.

The most expensive drugs are those that don’t work and don’t cure the sick. They may be very cheap but if the patient does not get well, or worse, developing new diseases as the virus, bacteria, or other causes of the disease are mutating and evolving into more dangerous strains, then the initial cheap treatment may turn out to be actually expensive. Thus, early and effective treatment is important, involving not only medicines but also other preventive measures like proper diet, avoiding food, drinks, smoking and other lifestyles that can aggravate the problem.

I am excited to be part of this big regional conference, not only to impart my knowledge and perspectives on the issue assigned to me, be questioned later, but more to learn from other speakers and participants in the various panels. After all, life is all about learning, endless learning, to better improve our own lives and that of our community and society.