Drug Innovation 12: H7N9, SARS, Bird Flu and Vaccines

Today, I read three stories of the SARS-like virus that has affected Saudi Arabia, and bird flu virus in  China.

Some 15 people have already died in Saudi Arabia alone, from SARS-like coronavirus. There are some panic especially in the eastern part of the country. See the news here.

A follow up article, also today, New SARS-like virus can probably pass person-to-person. In one family alone in Eastern Saudi Arabia, the father died and the three children got sick too with similar symptoms, two are in the ICU already. 

Then the news in China with 35 deaths already from a strain of H7N9 bird flu virus, out of 130 reported cases. News story here. All these three stories are from interaksyon.com.

Diseases indeed mutate. They are not dead or static, they are living and evolving micro organisms that want to expand themselves as fast as possible and claim more victims.

And that is why medical treatment, medicines and other aspects of healthcare must continue to evolve too. And some government policies that can discourage such continued innovation should be discouraged instead.

Reiner Gloor of PHAP has two articles last month on vaccines and preventive healthcare, especially in protecting children. Posting them below.

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http://www.bworldonline.com/content.php?section=Weekender&title=R&D-supports-Decade-of-Vaccines&id=68873

Posted on April 18, 2013 05:51:09 PM

Medicine Cabinet -- Reiner W. Gloor

R&D supports Decade of Vaccines

PREVENTING diseases remains the most important health strategy that eliminates the burden of social and financial risks associated with curative or palliative care. Vaccination has saved about 2.5 million lives each year, making it one of the most important and cost-effective public health innovations.

The 65th World Health Assembly (WHA) acknowledged, “vaccination is, and should be recognized as, a core component of the human right to health and an individual, community and governmental responsibility.” The WHA added that as an integral part of a comprehensive package for disease prevention and control, vaccines and immunization are investment in the future of a country.

In the Philippines, President Benigno Aquino himself recognized immunization as part of his priority universal health care agenda. He said that to win the war on poverty, the country must also turn its attention to public health.

“And, as we focus on the health of our country, economy, government, the overall health of all Filipinos also remains a top priority. We want our people to be empowered individuals capable of standing on their own two feet -- strong, healthy, and skilled men and women who can take advantage of the opportunities that life affords them,” he said during the launch of the an immunization program targeting 700,000 poor children.

Introduced at the World Economic Forum in Davos, Switzerland in January 2010, the global health community made a call for a Decade of Vaccines (DoV) which vision is a world in which all individuals enjoy lives free from vaccine-preventable diseases. The mission of the Decade of Vaccines is to extend, by 2020 and beyond, the full benefit of immunization to all people, regardless of where they are born, who they are, or where they live.

The Bill & Melinda Gates Foundation pledged $10 billion for the research, development and delivery of vaccines for the world’s poorest countries. The Foundation projected that about 7.6 million children under five will be saved from life-threatening diseases by increasing vaccines coverage in poor countries by 90%.

Drug Innovation 7: IFPMA, Superbugs and Tropical Diseases

People's lifestyle and communities evolve and continuously change. Their expectations, patience or impatience for more modern lifestyle, including more modern treatment in case they get sick, also evolve and changes. That is how modern medical science, pharmaceutical R&D, diagnostic tests and other aspects of the healthcare industry evolve.

I am reposting below three nice articles by the Executive Director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), Mr. Reiner Gloor. These are about the role of drug innovation and how to better encourage it, not demonize it. These appeared in his weekly column in BusinessWorld.

Protecting intellectual property rights (IPR) like drug patents is an important policy measure by governments to encourage innovation. Policy reversals like promoting compulsory licensing (CL) and other variants of IPR confiscation can only discourage innovation. After spending 10 to 14 years in various clinical trials and drugs R&D, and some $1 B or more per candidate drug molecule, it is not wise for governments to simply coerce the innovator companies to give away those efforts to other companies which did not spend equal amount of time and money to develop more revolutionary and more disease-killer medicines.

I have argued it over and over in this blog and other papers, that the main function of government is to promulgate the rule of law, protect private property rights, and the citizens' liberty, freedom of expression and freedom from aggression by bullies. Protecting IPR is consistent with this government role.

The three papers are entitled "Impact of innovation", "Protecting innovation", and "Encouraging innovation". Enjoy reading.

(1) Impact of innovation

Posted on 05:03 PM, November 08, 2012

Medicine Cabinet -- Reiner W. Gloor

http://www.bworldonline.com/weekender/content.php?id=61108

THERE was a time when infectious diseases such as pneumonia, typhoid fever and tuberculosis ravaged people around the world with no medicines available to treat or prevent them.

Alexander Fleming’s discovery of penicillin and subsequent research yielded new antibiotics that continue to protect the people from simple to complex infections. Since the 1920s, scientists also had their eyes on prevention, management and even cure for non-communicable diseases. Now, thousands of medicines have been produced to treat or prevent diseases, thanks to pharmaceutical innovation.

During the biennial conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva last week, the global research-based medicines industry called for a shared commitment to promote global health through the promotion of further innovation.

These medical innovations, along with other health interventions, have, after all, helped in beating polio on a global scale, and prevented measles, mumps, rubella and other ailments.

IFPMA President Dr. John Lechleiter said that in the past decade alone, vaccines for measles, polio, and diphtheria-tentanus-pertusis have saved the lives of an estimated 21.2 million children under the age of five each year.

He added that between 2000 and 2006, immunization campaigns reduced the number of deaths caused by measles by 68% worldwide and 91% in Africa. Furthermore, immunizations provided to nearly 300 million children in 72 developing countries have saved over five million lives. Reports also showed that global infant mortality fell from 77 deaths per 1,000 births to 62 or a reduction of 20% between 2000 and 2009.

Innovations in medicine have also helped increase cancer survival rates, and dramatically reduce deaths due to HIV/AIDS.

Biopharmaceutical research is likewise being focused on non-communicable diseases such as cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers that have grown to become the world’s biggest killers.

The biopharmaceutical sector has similarly invested heavily on understanding so-called rare diseases or those which affect fewer than 200,000 people. A deeper look at an individual’s genetic make-up is putting personalized medicine in the forefront of today’s innovation so that detection, treatment and prevention of the disease will be more tailored to the needs of each patient (For more information on personalized medicine, go to www.innovation.org.)

People are also living longer due to medical innovations. In illustrating this, a child born in 1955 had an average life expectancy at birth of only 48 years. In 2000, a child could expect to live 66 years. Life expectancy will increase to 73 years in 2025, it is said. Dr. Lechleiter commented that developing countries are seeing the most rapid gains.

Professor Frank Lichtenberg of Columbia University disclosed “new medicines accounted for 40% of the increase in life expectancy during the 1980s and 1990s in 52 developed and developing countries.”

Apart from the impact to life and health, biopharmaceutical innovations also resulted in economic gains by way of years of productive work, economic value added, consumer spending, and taxes paid.

No less than the World Health Organization (WHO) said that a nation needs a healthy population to achieve economic development. In fact, the 2001 report by the WHO Commission on Macroeconomics and Health stated that “health is a creator and pre-requisite of development.” It emphasized that increasing the coverage of health services and a small number of critical interventions to include the world’s poor could “save millions of lives, reduce poverty, spur economic development, and promote global security.”

The IFPMA Assembly also pointed out that there is strong evidence that innovative medicines are the most cost-effective part of health care. In another study, Mr. Lichtenberg found that for every $1 spent on new medicines for cardiovascular diseases in Organization for Economic Cooperation and Development (OECD) countries, close to $4 were saved in hospitalization and other healthcare costs.

More than economic gains are the social impact of medical innovations on patients who may be our children, siblings, parents and friends.

These days, a diagnosis of a disease does not necessarily mean an end to ties with families and friends.

These gains and the processes that these innovations go through must not be taken for granted. As Mr. Lechleiter said, we must build upon and not rest upon the contributions of the past. For despite our tremendous progress, much more remains to be done.

Childcare 9: Immunization and Government

Immunization of children of some preventable infectious/communicable diseases, well those diseases that tend to victimize the young and which there are existing vaccines already, whether patented or off-patent, is one important role that governments can provide. So again, I am no health anarchist, rather a health (or other social issues) minarchist.

For lifestyle-related diseases affecting many adult people, government should step back, allow people to take more personal responsibility in running their own lives. They can purchase private health insurance for instance, since they have the resources to buy plenty of alcohol and/or tobacco products, plenty of money to over-eat high-fatty, high-salt fast food, it should be fair that they also set aside money for their private health insurance, on top of government mandatory health insurance. This is one government coercion that is difficult or almost impossible to be shrunk and limited.

Sharing below three articles by the Executive Director of PHAP, Reiner Gloor, on immunization and vaccination of children, published in his column in BusinessWorld. These papers are about (a) immunization, (b) controlling pneumonia, and (c) anti-flu vaccines.

(1) Immunization as national priority  

July 13, 2012
Medicine Cabinet -- Reiner W. Gloor

http://www.bworldonline.com/weekender/content.php?id=55029

Ministers of health from 194 countries recently endorsed a global roadmap to prevent millions of deaths by 2020 through wider and sustained access to vaccines.

During the 65th World Health Assembly, health ministers set into action the Global Vaccine Action Plan (GVAP) that hopes to achieve an ambitious vision of a world where all individuals and communities enjoy lives free from vaccine-preventable diseases in a decade’s time until 2020.

The mission of the so-called Decade of Vaccines is to extend, by 2020 and beyond, the full benefit of immunization to all people, regardless of where they are born, who they are or where they live.

During the decade, one of the goals is to achieve commitments to eliminate and eradicate poliomyelitis, measles, rubella and neonatal tetanus at the global or regional level. The GVAP emphasized that attaining the goal within the decade is critical as success will encourage the realization of further goals while “failure means millions of preventable cases of disease and death will continue to occur.”

Apart from saving millions of lives by the end of the decade, realization of immunization-specific goals will result in economic productivity gains and at the same time, contribute to exceeding the Millennium Development Goal 4 to reduce child mortality by two thirds.

It is estimated that about 26 million future deaths could be prevented if the coverage targets for introduction and/or sustained use of 10 vaccines are met in 94 countries within the decade. The said estimate is for the 10 vaccine preventable diseases: hepatitis B, Haemophilus influenzae type b, human papillomavirus, Japanese encephalitis, measles, meningococcus A, pneumococcus, rotavirus, rubella and yellow fever.

Hopes are high about reducing vaccine preventable diseases following important milestones including the development, licensure and introduction of new and improved vaccines and technologies for high-burden diseases.

However, the GVAP stressed that these accomplishments will not be sustained unless countries take full ownership of their routine immunization programmes. As such, one of the six strategic objectives of GVAP to achieve the goals of the Decade of Vaccines is for all countries to commit to immunization as a national priority.

Acknowledging the value of immunization as an important public health intervention to save lives is the first step. Setting national targets and providing needed financial and human resource investments are relevant to demonstrate commitment to immunization.

Childcare 8: Vaccines and EINC

My two daughters are still young, my eldest is turning only six years old this coming October. This is a result of my getting married late. Nonetheless, getting them their regular shots of vaccines -- medicines injected into children and adults when they are not sick, to prevent or limit getting sick of certain diseases someday -- can be an expensive but necessary undertaking. I remember my eldest protesting loudly when we have to bring her to her pediatrician, "Papa, I'm not sick, I don't want injection!" It's good that she has overcome her fear of the needles many months ago.

I am sharing three articles by Reiner Gloor, Executive Director of PHAP, on vaccines and Essential Intrapartum and Newborn Care (EINC) to protect both mothers and babies/children, posted in his weekly columns in BusinessWorld on dates indicated.

I am no fan of high government involvement in healthcare as I believe that healthcare is first and foremost, a personal and parental/guardian responsibility. But for infectious and communicable diseases, I would give credit to government involvement on treating children's diseases and preventive healthcare via vaccination. Below are the three articles by Reiner.

(1) Decade of vaccines

June 29, 2012
Medicine Cabinet -- Reiner W. Gloor
http://www.bworldonline.com/weekender/content.php?id=54260

In 1736, Benjamin Franklin stressed the importance of fire prevention when he said that "an ounce of prevention is better than cure." Franklin would have not realized that his advice would go beyond fire fighting and have important public health implications today.

Preventing diseases remains the most important health strategy that eliminates the burden of social and financial risks associated with curative or palliative care. Along with improved sanitation and water safety, vaccination is one of the most important and cost-effective public health innovations, and has saved about 2.5 million lives each year.

In May this year, the 65th World Health Assembly (WHA) acknowledged, "vaccination is, and should be recognized as, a core component of the human right to health and an individual, community and governmental responsibility." It added that as an integral part of a comprehensive package for disease prevention and control, vaccines and immunization are investments in the future of a country.

Immunization helps protect children so that they may have the opportunity to achieve their full potentials. The World Health Organization (WHO) disclosed that as a result of immunization, along with other health care and development interventions, the number of deaths among children under five fell from an estimated 9.6 million in 2000 to 7.6 million in 2010, despite an increase in the number of children born each year. Vaccinations are likewise enabling adults and the elderly to live more productive lives.

While the last century was the so-called "century of treatment" following the discovery and use of antibiotics, the WHA is confident that this century will be the "century of vaccines" with the potential to address a number of serious, life-threatening or debilitating infectious diseases.

In the last 10 years, research and development came up new sophisticated vaccines such as pneumococcal vaccines and vaccines against rotavirus and human papilloma virus. Meanwhile, several vaccines are in development for neglected tropical diseases such as dengue, cholera and malaria. Also in the pipeline are vaccines for various types of cancer, allergy, HIV and other infectious diseases, as well as neurological disorders, among many others.

The WHO said that there are now vaccines to prevent or control about 25 infections.

Vaccines against hepatitis B and Haemophilus influenzae type b have become part of national immunization schedules around the globe. Poliomyelitis is close to eradication while a huge number of deaths from measles are being prevented every year. The number of deaths caused by measles, neonatal tetanus, pertussis and poliomyelitis fell from an estimated 0.9 million in 2000 to 0.4 million in 2010. (For the full report, go towww.who.int)

Milestone have been achieved with the commitment and support of governments and international stakeholders. The immunization program data for 2010 revealed that 154 of the 193 WHO Member States have specific budget line item for immunization, while 147 have developed multi-year national plans to sustain and/or enhance the campaign and introduce new vaccines.

In the Philippines, the Department of Health (DoH) implemented the Expanded Program on Immunization (EPI), established in 1976 to ensure that infants/children and mothers have access to routinely recommended infant/childhood vaccines. Initially included in the EPI are tuberculosis, poliomyelitis, diphtheria, tetanus, pertussis and measles vaccines.

Childcare 7: Reducing Child Mortality

Two weeks ago, there was another good news in the health front from The Economist blog, that "Africa is experiencing some of the biggest falls in child mortality ever seen."

http://www.economist.com/blogs/graphicdetail/2012/05/daily-chart-12

Good news from Africa

May 18th 2012, 16:10 by The Economist online

CHILD mortality in Africa has plummeted, belying the continent’s “hopeless” reputation. The chart below shows the change over the most recent five years in the number of deaths of children under five per 1,000 live births. It does so in 20 countries which have had demographic and health surveys (detailed surveys of living standards) since 2005. Sixteen of the 20 have seen falls, but the more impressive finding is the size of the decline in 12: more than the 4.4% annual fall needed for the world to achieve its millennium development goal of cutting by two-thirds the child-mortality rate between 1990 and 2015. The top performers, Senegal and Rwanda, now have rates the same as India. It took India 25 years to reduce its rate from around 120 child deaths per 1,000 births to 72 now. It took Rwanda and Senegal only about five years. Michael Clemens of the Centre for Global Development, a think-tank in Washington, DC, calls this “the biggest, best story in development”.

This is indeed good news. Make modern science and economic growth move to reduce child mortality and when those children become productive adults, they themselves will contribute to further improvement in modern science, economic growth and public health, especially in the area of infectious, non-communicable and tropical diseases.

Meanwhile, the World Health Assembly (WHA), a gathering of the Secretaries or Ministers of Health of WHO member-countries, has prioritized global vaccination.

http://www.who.int/immunization/newsroom/global_vaccine_action_plan/en/index.html
World Health Assembly endorses the Global Vaccine Action Plan and World Immunization Week

25 MAY 2012 - Ministers of Health from 194 countries at the 65th World Health Assembly endorsed the Global Vaccine Action Plan (GVAP), a roadmap to prevent millions of deaths by 2020 through more equitable access to vaccines for people in all communities. In addition, Member States also designate the last week of April as World Immunization Week.

Thirty-eight speakers including country delegates, partners such as UNICEF and GAVI Alliance and civil society organizations took the floor in massive support of the GVAP....

I will just add that such global action is not and cannot be limited to government efforts alone. There are many civil society organizations (CSOs) like health NGOs, international civic groups like the tens of thousands of Rotary Clubs under Rotary International (RI), church groups, private charity foundations like the Bill and Melinda Gates Foundation, many others.

Take for instance RI's  "End Polio Now" campaign. The Gates Foundation will donate $355 million over a number of years to RI (about a third of it I think, has been released) and the latter matched it with a counterpart fund of $200 million. There is only one goal for this large mobilization of private resources and donation: to help end polio worldwide.

I also noted a vaccination project for children 4-6 years old by some Rotary Clubs three years ago,  Childcare 2: Rotary DTP Vaccination, May 24, 2009.

While espousing free market solutions to many public health problems, I recognize there is a role for government (hence, I am no anarchist in public health policy) in dealing especially with infectious, pediatric diseases.
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See also:
Childcare 4: Treatment and Vaccines for Children's Diseases, February 28, 2012
Childcare 5: The 162 to 52 Summit, April 11, 2012
Childcare 6: On Vaccine Self-Sufficiency Project (VSSP), April 27, 2012 
Socialized Healthcare 4: On Health for All, May 02, 2012
Socialized Healthcare 5: Alterrnative Views on Universal Healthcare, May 23, 2012

Childcare 6: On Vaccine Self-Sufficiency Project (VSSP)

There is a new initiative by the Department of Health (DOH) through the Public-Private Partnership (PPP) to develop vaccine self-sufficiency project (VSSP). Here is the news report from BWorld:

http://www.bworldonline.com/content.php?section=Front-Page&title=Gov’t-readies-vaccine-PPP&id=49734

Posted on April 10, 2012 11:39:01 PM

Gov’t readies vaccine PPP

A MULTIMILLION-PESO domestic vaccine production project could be one of the next public-private partnership (PPP) deals to be rolled out by the government, officials yesterday said.

The P900-million Vaccine Self-Sufficiency Project (VSSP) Phase II, under the Department of Health, is up for approval today by an interagency committee after having been endorsed by a technical panel last week.

“The vaccine project is part of the agenda of the ICC Cabinet Committee meeting,” said Jonathan Uy, public investment staff director at the National Economic and Development Authority.

This followed approval by a technical panel of the Investment Coordination Committee, which evaluates major national projects and endorses it for final approval by the NEDA Board headed by the president.

PPP Center Executive Director Cosette V. Canilao said the VSSP involved the establishment of facilities for the formulation, packaging and labeling of the pentavalent -- used for diphtheria, pertussis, tetanus, hepatitis B and haemophylus influenza B; tetanus toxoid; and single dose hepatitis B vaccines.

“Private sector participation will include construction of the facilities, purchase of equipment and operation and maintenance for the next 10 years,” Ms. Canilao toldBusinessWorld.

“The invitation to prequalify to bid may be published in the second quarter, as soon as it is approved [by the NEDA Board],” she added.

In its Web site, the PPP Center said the project, which will be implemented through the Health department’s Research Institute for Tropical Medicine, is expected to reduce annual vaccine procurement costs by 20-30%.

“[The] government can save approximately P240 million to P360 million out of the P1.2-billion annual purchase cost of the vaccines,” the PPP Center said....

I think this is a good initiative by the DOH. Preventive healthcare via vaccination against common tropical diseases like diptheria, tetanus, pertussis (DTP) and hepatitis is a lot more efficient than curative healthcare. I am just wondering what is the exact role of the public sector here via the DOH, via prequalification of possible players?

This thing should better be left to the various private players in a competitive environment with the minimum intervention and bureaucracies from government agencies. What the DOH and the Food and Drug Administration (FDA) should do is to ensure bioequivalence testing of various vaccines that will be introduced in the local market by various players, to ensure that those drugs and vaccines that will be brought in are really safe and effective.

I will read more about this new initiative, but it is something that I can support -- more preventive healthcare, focus on infectious or communicable diseases, pediatric diseases. In order to have more resources for this initiative, the DOH and other government agencies should step back on subsidizing treatment of certain non-communicable diseases (NCDs) which are generally lifestyle-related.
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See also:
Childcare 2: Rotary DTP Vaccination, May 24, 2009
Childcare 3: My 2nd daughter, October 04, 2010
Childcare 4: Treatment and Vaccines for Children's Diseases, February 28, 2012
Childcare 5: The 162 to 52 Summit, April 11, 2012

Childcare 4: Treatment and Vaccines for Children's Diseases

Keeping with my philosophy that healthcare is first and foremost personal and parental/guardian responsibility, not government's, I will post related articles by other authors on how we parents and guardians should take more responsibility in taking care of our kids. I believe that government responsibility in childcare and controlling pediatric diseases is secondary to parental responsibility because the first line of defense towards  better health is preventive, not curative. Good nutrition and sanitation, 24/7 watch of babies to prevent injuries, sufficient vaccination, and so on. For children of poorer households, I will grant that there is a role for government, especially in timely vaccination against common pediatric diseases.

Below, I am posting two recent papers by a friend, Mr. Reiner Gloor, Executive Director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), on children's health, treatment and vaccines for known diseases affecting children. Enjoy.
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(1)  http://www.bworldonline.com/weekender/content.php?id=45315

Posted on 07:32 PM, January 19, 2012

Medicine Cabinet -- Reiner W. Gloor

Looking after children’s health

Reduction of infant and child mortality is one of the eight Millennium Development Goals that 189 countries, including the Philippines, committed to achieve by year 2015.

In 2010, these countries recommitted themselves to accelerate development towards achieving the time-bound targets involving health, poverty, education and gender equality, among others.

Significant progress has been made to reach the goal of reducing child mortality by two-thirds in time for the global deadline and the probability of meeting the target is high, according to a report by the National Economic and Development Authority (NEDA).

On the other hand, the United Nations Development Program (UNDP) indicated that global child deaths are falling but not quickly enough.
The UN agency disclosed that nine million children worldwide still die before they reach their fifth birthday.

This signifies that while important milestones have been achieved, efforts must be sustained to meet the goal.

The fight against diseases that affect children has been at the center of biopharmaceutical research and development (R&D).

Treatment advances have yielded new vaccines and medicines that protect children against many fatal childhood diseases, making pharmaceutical R&D for children one of the key contributors in achieving MDGs.

Generic Drugs Asia 4: Vaccines from China

I saw two news reports today re China's entry into the vaccine production and exportation industry. One is from AP and posted in yahoo news and other papers, the other is from the National Bureau of Asian Research (NBR).

The report written by Gillian Wong of AP says that China is still readying for this in the next few years, and not yet ready this year or next year or next 2-3 years. And the author also recognizes that there is that big question mark in the minds of the public in other countries about the quality of China-made drugs and food products due to several scandals of contaminated food manufactured in China. And here are parts of the report:

China prepares for big entry into vaccine market

China's vaccine-making prowess captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu — in just 87 days — as the new virus swept the globe. In the past, new vaccine developments had usually been won by the U.S. and Europe.

Then, this past March the World Health Organization announced that China's drug safety authority meets international standards for vaccine regulation. It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.
"China is a vaccine-producing power" with more than 30 companies that have an annual production capacity of nearly 1 billion doses — the largest in the world, the country's State Food and Drug Administration told The Associated Press.

But more needs to be done to build confidence in Chinese vaccines overseas, said Helen Yang of Sinovac, the NASDAQ-listed Chinese biotech firm that rapidly developed the H1N1 swine flu vaccine. "We think the main obstacle is that we have the name of 'made in China' still. That is an issue."

China's food and drug safety record in recent years hardly inspires confidence: in 2007, Chinese cough syrup killed 93 people in Central America; one year later, contaminated blood thinner led to dozens of deaths in the United States while tainted milk powder poisoned hundreds of thousands of Chinese babies and killed six....

At the NBR report last May 25, 2011, the interviewee, Jiankang (“Jack”) Zhang, China Country Program Leader of PATH, said:

Currently, China has 36 vaccine manufacturers that produce 49 types of vaccines against 27 diseases. The country’s annual manufacturing capacity is nearly one billion doses. WHO’s clearance opens the door for these companies to apply for WHO vaccine pre-qualification—a regulatory status that opens the door for United Nations agencies and governments to begin ordering the vaccine— with the aim of becoming eligible for vaccine procurement by the United Nations Children’s Fund (UNICEF).

In order to speed up the process of obtaining WHO pre-qualification, the Chinese government is now offering more support and encouragement to domestic vaccine manufacturers than ever before, particularly to state-owned enterprises such as China National Biotec Group (CNBG) and other leading vaccine companies. This top-down approach has proven to be the most efficient way to move things forward in China.

The announcement will motivate domestic manufacturers to strengthen vaccine development partnerships with international organizations at broader and more strategic levels. More government funding will also pour into companies working toward the goal of WHO pre-qualification. Furthermore, a new interest in vaccine technology will encourage Chinese scientists who are now working overseas to return to the country in order to leverage this opportunity....

See a longer interview here, A Pivotal Moment for China & Vaccine Manufacturing

During the Conference of Generic Drugs in Asia (CGDA) in Taiwan last week, Nov. 19-21, there was no speaker from China -- generic manufacturers or the State FDA or other industry associations from the health sector. I did not ask the organizers, FAPA and the Pharmaceutical Society of Taiwan why, I just assumed that perhaps it has something to do with the old China-Taiwan tension.

China is the homebase of generic drugs production worldwide. As of 2008, 97 percent of total pharma market by volume was already accounted for by generic drugs. See one graph there from Mr. Roy Fan in Generic Drugs Asia 3: FDAs and the Consumers, November 25, 2011. Next to China would be India, Brazil, Mexico, and other "pharmerging markets".

Given the aggressive development of future China-made vaccines because of the various incentives or subsidies to be extended by the China government, plus the high demand for cheaper vaccines worldwide, when supply meets demand in terms of low prices, the role of governments, especially the various Food and Drugs Administration (FDA) or similar bodies, is to protect public health via more stringent approval process for imported drugs and vaccines, against substandard and counterfeit ones.

But this is not a 100 percent viable scenario due to weak or limited resources and capacity of many FDAs in developing countries like the Philippines. So one "clearing house" scheme would be for those generic vaccine exporters from China and other countries to partner with existing and known pharma companies in the local market, both innovator and generics. The FDA can then focus on lesser-known or zero track record new players yet. This would sound "penalizing the smaller players". Somehow true, and this will encourage the new players to prove their worth, or to partner with more established players on some products.

On another note, there is also one good development in China that can help improve global confidence of their pharma products and exports. It is the establishment of anti-counterfeiting and intellectual property rights (IPR) protection agency.

Portions of the report, China plans state office for anti-counterfeiting, IP protection says,

The US government said just a few days ago that it had uncovered 1,800 instances of suspected counterfeit parts and equipment sold to the Department of Defense, for example, with China emerging as the most common country of origin.

The new office will exercise stricter supervision over manufacturers, in part through inspections, and encourage police forces and local government bodies across different regions in China to work together on investigations involving IPR infringement and product counterfeiting.

The State Council statement also calls for greater oversight of local government, tighter regulation of Internet trade and stronger penalties for those found guilty of partaking in this type of criminal activities.

China's Ministry of Public Security said earlier this month that police have solved 28,000 cases involving IPR infringement and counterfeiting over the course of a year-long crackdown on the activities, focusing on fake luxury goods, pirated books, audio and video and counterfeit medicines and foods.

All told the cases represent around 500 billion yuan ($80bn) worth of goods if calculated in terms of the prices of genuine, licensed products, said the Ministry...

See that? A communist government recognizing more and more the value of private property rights, whether physical property or intellectual property. This is because while the China government can arbitrarily disrespect such property rights within its national territory, it cannot do so in the international market.

By moving towards this direction, the China government -- and other developing country governments -- will recognize that IPR protection related to drug innovation, whether newly-developed drugs or generic drugs and vaccines, is important, both for corporate finance and business aspect, as well as protecting public health.

Childcare 2: Rotary DTP Vaccination

I belong to a small club, the Rotary Club of Taguig Fort Bonifacio of RI District 3830 and we do not have much community projects. But my District Governor when I was a Club President in RY 2006-07, Past District Governor (PDG) Rafael "Butch" Francisco, has a kind heart for our less privileged countrymen.

Yesterday, PDG Butch celebrated his birthday, May 23, among several thousand children 4-6 years old and their parents (mostly mothers), in Dipteria-Tetanus-Pertusis (DTP) vaccination project. It was held in Pasay Sports Plaza. I wasn’t there yesterday, but this morning, May 24, I attended the 2nd day of the activity. It was held in Malibay Sports Gym, also in Pasay.

The two-days activity was jointly sponsored by the Rotary Club of Pasay North, D3810, and Rotary Club of Paranaque East (RCPE), D3830. Funding for this rather expensive but worthy project mainly came from PAGCOR, Where PDG Butch is the President, in coordination with VAXEN, a young but big distributor of vaccines in the country. Other rotary clubs from D3830 also pitched in various support like food and drinks for the hundred-plus people involved in the 2-days activity.

The Pasay City government also extended support by mobilizing the city health and social welfare departments, their staff moving house to house to distribute pre-registration forms for families with children 4-6 years old. I think this is an efficient system. First, only parents or guardians of children 4-6 years will be given the registration form, and only the targeted beneficiaries, Pasay residents, will be served. Well if the sponsors bought vaccines for 4,000 children and 10,000 will come from various cities, then you will have logistical nightmares and thousands of disgruntled parents and guardians who will say more bad things than good about Rotary.

When I arrived at Malibay Sports Gym a little past 9am, there were hundreds of parents with their respective children already. I immediately went to Gov. Butch to greet him a (belated) happy birthday. As time goes, more parents with their toddlers were coming.

PP Rene Aquino of RCPE served as the MC. He briefly introduced what the project is all about, and what the vaccines can do for their children. The parents/guardians and their toddlers happily greeted Gov. Butch on his worthy birthday project.

PDG Butch (3rd from left) with RCPE guys.

Then the vaccination started. A long line of eager parents who will save some P1,000 for the vaccine if purchased in commercial clinics, was formed. There were 4 tables with 2 health personnel in each table, so 8 toddlers can be served at the same time. And this is where “children’s drama” unfurled.

Although about 70 percent of the children did not cry during the “injection”, a portion of the 30 percent who cried really cried wildly! I surmised they were already crying and resisting while queuing, and their screaming was directly proportional to their distance to the attending health personnel holding the syringe. That is, 2 meters away, the cries were loud. When they were face to face with the health staff, they were screaming to the top of their lungs, really huge teardrops, waggling and kicking, and looking at the health personnel as if the latter are the most evil persons on Earth!

Since I was finding out how I can help since the city welfare staff are in charge of making the long lines in order, I just went to those children who cried the loudest. I did not intend to pacify them because I knew they won’t listen to me since they do not know me, so I went to hold their waggling and kicking feet! When the “injection” is over – usually in just about 3 seconds – these children were wondering if all their resistance was worth the very brief pain of the needle. I was kidding their mothers or guardians, “mas mahaba pa ang iyak kesa injection ah”, to which they nodded smiling or laughing.

PDG Butch was walking around distributing lollipop candy to children who finish the “injection”. By that time, even those who cried wildly were already pacified. The parents were obviously very happy – you can see it in their eyes and smiles – that their toddlers now have protection against those 3 dangerous diseases.

With the quick and systematic vaccination process, the vaccination was over in about an hour covering several hundred, or perhaps a thousand, children. But the team did not leave since there were still other parents with their toddlers coming. They will wait and do their work until 3pm today, the designated closing time. I heard that the volume of children yesterday was much larger than today.

Projects like this makes you proud of being a Rotarian. When I got out of the sports gym, I realized I needed a haircut. Ahh, there’s a barber shop nearby...