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FOURTEENTH CONGRESS OF THE REPUBLIC 
Second Regular Session 
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OF THE PHILIPPINES 
S E N A T E  
Introduced by Senator Manuel “Lito” M. Lapid 
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EXPLANATORY NOTE 
Article 13, Section 12 of the 1987 Constitution provides that the State shall 
establish to undertake appropriate health manpower development and research, 
responsive to the country’s health needs and problems. 
Orphan, or rare, diseases are disorders or diseases which affect small 
patient populations. They do not attract very much public attention, research, or 
funding, typically because they are extremely rare or poorly publicized. 
Thousands of such diseases can be found worldwide, ranging from extremely 
rare genetic disorders like Fatal Familial Insomnia to tuberculosis, which do not 
attract attention in industrialized nations due to the low incidence of reported 
cases. Diseases which are common in the developing world but rare or unusual 
in the industrialized world are also called orphan diseases, because they fail to 
attract attention from major pharmaceutical companies. 
Many orphan diseases are genetic in nature, which can make them very 
challenging to study, let alone treat. Others take the form of extremely rare 
viruses, unusual bacteria, or peculiar allergies, and they may take time to 
diagnose, so they slip through the cracks for months or years until someone 
begins to connect multiple incidences of the same condition. Researchers such 
as epidemiologists are often more in touch with emerging diseases than others, 
but they cannot attract enough attention to extremely rare diseases to make the 
general public aware of the issue. 
For decades, many Filipinos suffering from a number of orphan diseases 
and disorders were denied access to 
effective medicines because 
pharmaceutical companies make little financial incentives to produce and market 
new medications to treat or prevent the same. Even with the pressing health 
need for these medications, they came to be known as ‘orphan drugs’ because 
no companies would commercialize them. 
This proposed measure seeks to provide a comprehensive program for 
health research on orphan diseases in the country and provide a national 
comprehensive information and education drive to inform the general public of 
the nature and mode of infection of orphan diseases. 
In view of the foregoing, early passage of this bill is earnestly sou 
MA 4 
L “LITO” 
Senator M. LAPID r“ ,. 


S. No. 3 3 3  
Introduced by Senator Manuel “Lito” M. Lapid 
AN ACT 
ESTABLISHING A HOLISTIC RESEARCH AND DEVELOPMENT 
PROGRAM ON ORPHAN OR RARE DISEASES, APPROPRIATING 
FUNDS THEREFOR AND FOR OTHER PURPOSE 
Be it enacted by the Senate and the House of Representatives of the 
Philippines in Congress assembled: 
SECTION 1. 
Short Title. - This Act shall be known as the “Orphan 
Diseases Act of 2009.” 
SEC. 2. 
Declaration of Policy. - It is hereby declared the policy of 
the State to protect and promote the right to health of the people to full, healthy 
and holistic development and the right to self-determination. As such, the State 
shall promote an environment conducive to the development of all its citizens to 
become, to the best of their potentials, independent, self-reliant and productive 
members of society. 
Towards this end, the State commits itself to the establishment of 
institutional mechanisms to provide quantitative and qualitative research on 
orphan (or rare) diseases that are responsive to the country’s health needs. 
SEC. 3. 
Definition of Terms. - For purposes of this Act, the following 
(a) 
“Committee” refers to the Committee on Orphan Diseases 
Research. 
(b) 
“Orphan Diseases” are disorders or diseases which affect small 
patient populations, do not attract very much public attention, research, or 
funding, typically because they are extremely rare or poorly publicized and do not 
attract attention in industrialized nations due to the low incidence of reported 
cases. 
terms shall be defined as follows: 
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(c) 
“Secrefary”shall refer to the Secretary of the Department of Health; 
SEC. 4. 
Comprehensive Research on Orphan Diseases. - The 
Secretary of the Department of Health (DOH) is hereby mandated to conduct a 
comprehensive research and information drive on the incidence and prevalence 
of orphan diseases in the country. The Department is also mandated to support 
medical and epidemiological research activities to expand the knowledge and 
understanding of orphan diseases in the country. 
The DOH is mandated to strengthen its research focus concerning orphan 
diseases, including a renewed investment into basic and clinical research, 
expanded research into the link between environmental factors and the diseases, 
and continued investigations into causation, diagnosis, and treatment. Such’ 
factors that will be studied shall also include, among others, infection and 
immune function, hormones and reproductive factors, genetic factors, gastro- 
intestinal factors, socio-demographic factors, and others. 
SEC. 5. 
Committee on Orphan Diseases Research. - To assist 
the Secretary in receiving accurate and complete information on orphan 
diseases, its symptoms, origins, classifications, preventions and treatment, there 
is hereby established a Committee, to be known as the Committee on Orphan 
Diseases, to ensure the strategic management, communication, and oversight of 
the policy formation, research, and activities of the government regarding these 
diseases. 
The Committee on Orphan Diseases Research shall endeavor to: 
a) 
promote public awareness, education and information on issues 
establish sustainable networks of support group for families of 
concerning orphan diseases; 
b) 
afflicted persons; 
c) 
provide referral services to patients with orphan diseases and 
identify the appropriate educational and medical expertise and facilities suited to 
the needs of the patients; 
d) 
combat the spectrum of medical problems related to orphan 
e) 
undertake research andlor collaborate with other entities on 
research activities regarding the prevalence of the orphan diseases in the 
Philippines; 
diseases through education, prompt referrals for treatment and services; 
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f) 
receive donations and grants from international donor institutions, 
foundations, and multilateral and bilateral forelgn donor agencies involved in 
research, prevention, cure and rehabilitation of persons with orphan diseases; 
g) 
provide the avenue for exchange of information, exchange 
programs and sharing of best practices on issues relating to prevention, cure, 
treatment and rehabilitation of afflicted patients; and 
h) 
ensure that materials concerning the disease are available, up to 
date, and responsive to reports of problems with orphan diseases, and that 
timely aggregate data concerning such reports shall be made available to the 
public upon request and consistent with existing confidentiality standards. 
SEC. 6. 
Composition. - The Committee on Orphan Diseases 
Research shall be composed of the following members: 
One (1) representative from the Department of Health (DOH); 
One (1) representative from the National Institute of Health (NIH); 
One (1) representative from duly accredited association of drug and 
vaccine manufacturers and distributors; 
One (I) 
representative from the duly accredited association of 
hospitals in the Philippines; 
One (1) representative from the duly accredited association of 
medical doctors in the Philippines; and 
One (1) representative from non-governmental organizations 
(NGOs) involved in the advocacy for the prevention, cure and 
rehabilitation of persons with orphan disease. 
The Secretary shall be the Chairperson ofithe Committee. 
SEC. 7. 
Meefings. - The Committee shall meet at least once a 
month upon three-day notice signed by the two ~(2) Chairpersons or as often as 
necessary upon the written request signed by &+thirds (313) of its members. 
The presence of a majority of the members of the Committee shall 
constitute a quorum in order for it to conduct its business. 
The meetings of the Committee shall be open to the public and public 
witnesses shall be given the opportunity to speak and make presentations at 
such meetings. 
Each member shall make a presentation to the full Committee at each 
meeting concerning the activities conducted by such member. 
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SEC. 8. 
Intervention for Persons with Orphan Diseases. - The 
DOH is hereby mandated to establish a program for identification and detection 
of persons with orphan disease. 
SEC. 9. 
Prevention of Conflict of Interest in the Research 
Process, - Within six (6) month from the date of effectivity of this Act, the DOH 
shall issue the necessary standards, guidelines and regulations in order to 
ensure that there is no conflict of interest between the research agenda of the 
researchers and the drug manufacturers or government agencies promoting the 
widespread usage of a particular vaccine or medicine for the treatment and 
rehabilitation of persons with orphan disease. 
The DOH shall ensure the timely publication and dissemination of 
information of these guidelines and regulations in order to ensure that the various 
health providers and stakeholders all over the country are adequately informed. 
SEC. I O .  
Appropriations. - To carry out the provisions of this Act, 
the funds necessary to implement the provisions of this Act shall be incorporated 
in the annual general appropriations of the Department of Health. 
SEC. 11. 
Separabilify'Clause - If any provision or part hereof is held 
invalid or unconstitutional, the remainder of the law or the provision not otherwise 
affected shall remain valid and subsisting. 
SEC. 12 
Repealing Clause - Any law, presidential decree or 
issuance, executive order, letter of instruction, administrative order, rule or 
regulation contrary to or inconsistent with the provision of this act is hereby 
repealed, modified or amended accordingly. 
SEC. 13. 
Effectivity Clause. - This Act shall take effect fifteen (15) 
days from the date of its complete publication in the Official Gazette or in at least 
two (2) newspapers of general circulation. 
Approved, 
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