Tuesday, December 04, 2012

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


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 

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.

(2) Protecting innovation

Posted on November 15, 2012 07:08:56 PM

Medicine Cabinet -- Reiner Glo


THE IMPACT of pharmaceutical innovation to help prolong and improve the health and lives of patients and their families cannot be overemphasized. Economic gains also come with biopharmaceutical innovations by way of more years of productive work, sparking growth and development.

The global research-based medicines industry recently called for a shared commitment to foster global health through the promotion of further innovations to sustain their benefits to patients, families and societies.

For one, people are living longer due to medical innovations. Life expectancy is said to increase to 73 years in 2025. 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.

Biopharmaceutical research is likewise on the trail for medicines that could address the growing epidemic of non-communicable diseases such as cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers.

At the moment, there are close to 900 potential medicines for cancer; more than 200 potential medicines for cardiovascular disorders, and nearly 200 for diabetes; about 80 potential medicines for HIV/AIDS; and about 300 medicines for rare diseases.

But while there have been great moments in innovation in the past, much more remains to be done in the ambitious search for life-saving medicines.

For one, there are the Neglected Tropical Diseases that “persist under conditions of poverty and are concentrated almost exclusively in impoverished populations in the developing world.” These are dengue, malaria and schistosomiasis among many others.

Innovations are also needed for diseases “that come with little warning” such as the H1N1 virus, which became a pandemic in 2009. The World Health Organization (WHO) said that the future impact of the H1N1 virus is not possible to predict.

More people are anticipated to develop immunity to the current version of the H1N1 virus as it circulates as a seasonal influenza strain. On the other hand, there is need to continue biopharmaceutical innovations as the virus is also expected to change over time due to antigenic drift. The WHO said that these changes might mean that the immunity may become less protective against future strains of this virus.

There are also infections caused by resistant microorganisms to include the so-called superbugs that do not respond to the “last line of defense” antibiotics.

As the people start living longer and longer, diseases like cancer and Alzheimer’s require sustained innovations and new medical breakthroughs.

On the other hand, developing new medicines have become more challenging, expensive and complex.

The IFPMA noted that with the exception of 2011, new drug approvals have been on downward trend. In the five-year period from 2006 to 2010, there were 151 new medicines launched globally, down from 211 in the five-year period a decade earlier or a 30% decline. The pharmaceutical sector is also in the midst of seeing some $150 billion of branded pharmaceutical products lose patent protection. Moreover, 26 major independent pharmaceutical companies have consolidated into nine over the past 20 years.

IFPMA President Dr. John Lechleiter said that the challenge is to sustain the innovation required to conquer diseases and maintain the trajectory of longer, healthier lives. At the same time, there is need to continually expand access to quality health care for the large percentage of the world’s population without it today.

Lechleiter said that elements of an “ecosystem” of innovation include sound intellectual property and a regulatory system that keeps pace with 21st century science.

He said that the work of innovation is not possible and cannot be sustained without solid intellectual property (IP) protection, which is the lifeblood of any endeavors generating value from ideas.

On average, it takes close to 14 years and $1 billion to bring a new medicine from discovery to medicine cabinet. Without IP protection, medical innovation would not be sustainable.

Lechleiter added that the benefits of IP protection include not only breakthrough medicines, but a broad range of low-priced generic medicines, which are an important legacy of the innovative research-based industry.

Given the challenges in developing new medicines, the global research group called for predictability and certainty in the regulatory process that will help determine when and whether or not new medicines will ever reach patients. Finally, regulatory processes must likewise be “timely, predictable, consistent, transparent, and scientifically rigorous.”

(3) Encouraging innovation

Posted on 04:56 PM, November 22, 2012

Medicine Cabinet -- Reiner Gloor


PROPONENTS are lauding the recent Senate passage of the so-called sin tax bill as a historic move that would expedite the attainment of universal health care in the country.

Senate Bill No. 3299, or "An Act Restructuring the Excise Tax on Alcohol and Tobacco Products," was passed on third and final reading in a bid to generate about P40 billion incremental revenues for health programs as well as curb smoking especially among the youth.

The revenue raised from increased tobacco and alcohol taxes will be used to widen PhilHealth coverage and expand its support value such as the no-balance billing, and inclusion of catastrophic and outpatient benefits.

Being a health measure, the Department of Health (DoH) is eyeing to enroll 10.9 million poorest families to PhilHealth. Additional funding will also be used for the immediate upgrading and modernization of government hospitals and health facilities so that all rural health units meet accreditation for outpatient benefits, TB-DOTS, and maternal and child health accreditation. From the funds raised by the tax, all district hospitals will have operating rooms and be able to do emergency operations such as caesarian sections, chest tube insertions and appendectomies.

It is also envisioned that all DoH facilities would become modern medical centers, with seven strategically located center of excellence nationwide for cardiac problems, oncology and renal transplantation.

Given a bigger allocation from the new excise tax, the government would hire additional 10,000 doctors, 50,000 nurses, dentists and midwives, as well as deploy 100,000 community health teams.

Furthermore, the DOH seeks to expand the immunization program to include rotavirus and pneumococcal vaccines for all children; eradicate malaria, rabies, schistosomiasis, and other public health diseases; and establish a sustainable program for non-communicable diseases prevention and control, including health promotion.


Biopharmaceutical innovations have played a key role in the global and national programs to prevent, control and cure major non-communicable diseases (NCDs) such as cardiovascular diseases, cancer, chronic respiratory diseases and diabetes. Health experts say that most of these major NCDs are tobacco-related.

Partly due to medical innovations, people are now living longer and having more chances of surviving infectious and major NCDs.

The global research-based medicines industry recently called for a shared commitment to foster global health through the promotion of further innovations to sustain their benefits to patients, families and societies. Such a call not only boosts the discovery of breakthrough medicines, but also ensures the availability of broad-range, low-priced generic medicines for greater access to scientifically researched treatments.

While there have been giant leaps in innovation in the past, much more remains to be done in the ongoing search for new medicines. However, the research and discovery process has been associated with "high scientific, regulatory and economic risks" as there are no guarantees of success in the laboratory or approval stage.

Recognizing the need to encourage medical advances, the International Federation of Pharmaceutical Manufacturers and Associations recently released a report by the Charles River Associates on the conditions necessary to spur biopharmaceutical innovation in middle-income countries. The report said that there are now observable pharmaceutical R&D activities in middle-income countries.

It stated that between 2005 and 2010, the R&D spend by members of the Pharmaceutical Research and Manufacturers of America increased by 455% in Asia-Pacific (excluding Japan), 112% in Latin America, 303% in India. The report added that there has also been an increase in terms of innovative outputs in middle-income countries like Brazil, China, Colombia, India, Malaysia, Russia, South Africa and South Korea.

The report cited the need for consistent and long-term policies and legal framework on pharmaceutical innovation to generate innovative activities, specifically in early stage research.

The report highlighted that the impact of stronger Intellectual Property protection can be observed in many of the countries covered by the study. On average, it takes close to 14 years and $1 billion to bring a new medicine from discovery to the medicine cabinet. Without intellectual property protection, medical innovation would not be sustainable.

E-mail the author at reiner.gloor@gmail.com. Join www.facebook.com/people/Pharma-Phap/.

See also: 
Drug Innovation 3: Biopharmaceutical R&D and Innovation, June 01, 2012
Drug Innovation 6: Dealing with Drug-Resistant TB, November 30, 2012

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