Wednesday, November 23, 2011

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,

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.

1 comment:

Unknown said...

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Pharmacy Manufacturer