Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
Second Regular Session 
HOUSE BILL NO. 9867 
Introduced by 
SPEAKER FERDINAND MARTIN G. ROMUALDEZ 
HON. YEDDA MARIE K. ROMUALDEZ 
HON. JUDE A. ACIDRE 
and 
HON. CIRIACO B. GATO, JR.  
AN ACT TO ACCELERATE THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE 
MEDICINES BY STRENGTHENING CLINICAL TRIALS, AND FOR OTHER 
PURPOSES 
EXPLANATORY NOTE 
With the passage of Republic Act No. 11223, or the Universal Health Care Act, it 
has been the government’s policy to adopt a healthcare model that provides every Filipino 
with cost-effective, quality, preventive, curative, rehabilitative, and palliative health 
services. In line with this policy, the conduct of clinical trials has been recognized as a 
scientific and research-based approach that helps medical researchers and developers 
optimize benefits, reduce risk, and ensure the safety and efficacy of innovative medicines. 
Focus on such government policy has been proven to be timely as the need of the 
Filipino people for better healthcare increases. With 96%1 of Filipinos believing that the 
government should have a greater role in affordable and comprehensive medicine 
1 96% of adult respondents agree that the government “should definitely” (78%) and “should probably” (17%) provide free medicines 
to those who need them. [SWS. 2021] 
February 5, 2024
8:00 am


access, this is an opportune time to strengthen the role of government in supporting 
research and development activities for innovative healthcare services. 
Currently, clinical trial activities in the Philippines are heavily supported by the 
private sector, with government lending its support through regulation by the Department 
of Health (DOH) and the Food and Drug Administration (FDA). For decades, research-
based pharmaceutical companies have invested significant amounts in the conduct of 
clinical trials in the country, resulting in the Philippines being recognized as a leader in 
the conduct of clinical trials.2  
However, recent data has shown that since 2014, there has been a steep decline 
in the number of new clinical trials conducted in the Philippines, which decline has 
widened the gap between the Philippines and other leading countries.3 This decline has 
contributed to innovative medicines being inaccessible to Filipino citizens, with only 1 out 
of the 166 innovative medicines launched internationally making it to the Philippine 
National Formulary.4 
As such, there is a need to revitalize the Philippines as a regional center of 
excellence in the field of clinical trials and improve access to innovative medicines by 
rebuilding and redesigning our clinical trial system, through the establishment of an 
Experimental Drug Development and Discovery Center. 
In view of the foregoing, approval of this bill is earnestly sought. 
2 FDA Circular No. 2012-007 
3 Citeline, 20 May 2020. Number of New Clinical trials per year, Southeast Asia, 2000-2019 
4 IQVIA. 2019. Access to Innovation. 


Rep. FERDINAND MARTIN G. ROMUALDEZ 
Representative, 1st District of Leyte 
Rep. YEDDA MARIE K. ROMUALDEZ 
Representative, Tingog Sinirangan 
Rep. JUDE A. ACIDRE 
Representative, Tingog Sinirangan 
Rep. CIRIACO B. GATO, JR.  
Representative, Lone District of Batanes 


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
Second Regular Session 
HOUSE BILL NO. 9867 
Introduced by 
SPEAKER FERDINAND MARTIN G. ROMUALDEZ 
HON. YEDDA MARIE K. ROMUALDEZ 
HON. JUDE A. ACIDRE 
and 
HON. CIRIACO B. GATO, JR.  
AN ACT TO ACCELERATE THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE 
MEDICINES BY STRENGTHENING CLINICAL TRIALS, AND FOR OTHER 
PURPOSES 
Be it enacted by the Senate and House of Representatives of the Philippines in Congress 
assembled: 
CHAPTER 1 
GENERAL PROVISIONS 
Section 1. Short Title. – This Act shall be known as the “Pharmaceutical 
Innovation Act.” 
Section 2. Declaration of Policy. –  It is recognized that well-designed and well-
implemented clinical trials are indispensable for the discovery and development of 
innovative medicines and for assessing the safety and efficacy of health interventions and 
in informing associated comparative cost-effectiveness evaluations vis-à-vis existing 
interventions with a view to promoting the affordability of health products. Accordingly, it 


is hereby declared a policy of the State to accelerate the discovery and development of 
innovative medicines by strengthening clinical trials in a manner that addresses public 
health priorities and the health needs of Filipinos. For this purpose, the Government shall 
establish a national experimental drug discovery and development center, which shall aim 
to develop innovative medicines, and that will work collaboratively with the public sector 
and industry partners. 
 
Section 3. Definition of Terms. – For purposes of this Act, the following terms 
shall have the meanings provided below: 
 
(a) “Access to innovative medicines and investigational products” refers to the 
capability of the patient to timely and equitably receive innovative and/or 
investigational medicines that deliver the intended and sustainable outcomes. 
 
(b) “Clinical Research Organization” refers to a person or an organization 
(commercial, academic or others) contracted by a sponsor to perform one or 
more of the sponsor’s trial-related duties and functions. 
 
(c) “Clinical Trial” refers to any investigation in human subjects intended to 
discover 
or 
verify 
the 
clinical, 
pharmacological 
and/or 
other 
pharmacodynamics effects of an investigational product(s), and/or to identify 
any adverse reactions to an investigational product(s), and/or to study 
absorption, distribution, metabolism, and excretion of an investigational 
product(s) with the object of ascertaining its safety and/or efficacy. 
 
(d) “Innovative medicine” refers to any novel drug, active pharmaceutical 
ingredient or molecule that does not contain or include indication, product, or 
brand name of existing pharmaceutical ingredient or molecule (e.g., generic 
equivalent, biosimilars) registered with the Food and Drug Administration. 
 
(e) “Investigational product” refers to a pharmaceutical form of an active ingredient 


or placebo being tested or used as a reference in a clinical trial, including a 
product with a marketing authorization when used or assembled (formulated 
or packaged) in a way different from the approved form, or when used for an 
unapproved indication, or when used to gain further information about an 
approved use. 
 
(f) “Managed entry agreements” refers to arrangements or patient access 
schemes that enable access to innovative medicines and investigational 
products. 
  
(g) “Medicine” refers to any chemical compound or biological substance, other 
than food, intended for use in the treatment, mitigation, prevention, or 
diagnosis of disease in humans or animals, including but not limited to: 
 
1. any article recognized in the Philippine Pharmacopoeia, Philippine 
National Drug Formulary, or in any foreign official pharmacopoeias and 
formularies which are adopted by the Food and Drug Administration or any 
document supplementary to any of them;  
2. any article, other than food, intended to affect the structure or any function 
of the human body or animals; 
3. any article intended for use as a component of any chemical compound or 
biological substance or articles specified above, not including devices or 
their components, parts, or accessories; and, 
4. herbal and/or traditional drugs, and the components thereof, which are 
articles of plant or animal origin used in folk medicine, which are: 
i. recognized in the Philippine National Formulary; 
ii. intended for use in the treatment, cure, mitigation, prevention, 
or diagnosis of disease symptoms, injury, or body defects in 
humans; 
iii. other than food, intended to affect the structure or any 
function of the human body; 


iv. in finished or ready-to-use dosage form; or 
v. intended for use as a component of any of the articles 
specified in clauses (i), (ii), (iii) and (iv) above. 
 
(h) “Sponsor” refers to a natural or juridical person that is responsible for the 
initiation, management and/or financing of a clinical trial. 
 
(i) “Philippine National Health Research System (PNHRS)” refers to the 
framework anchored on the principles of Essential National Health Research 
on inclusiveness, participation, quality, equity, efficiency and effectiveness, 
institutionalized within the mandate of the Philippine Council for Health 
Research and Development (PCHRD) of the Department of Science and 
Technology (DOST) under Republic Act No. 10532, otherwise known as the 
Philippine National Health Research System Act of 2013. 
 
CHAPTER 2 
EXPERIMENTAL DRUG DEVELOPMENT AND DISCOVERY CENTER 
 
Section 4. Experimental Drug Development and Discovery Center. – To 
improve access to innovative medicines and investigational products by strengthening 
clinical trials and to carry out the provisions of this Act, an Experimental Drug 
Development and Discovery Center is hereby established which shall serve as the 
collaborating hub on all matters regarding pharmaceutical research and development in 
the Philippines. 
 
The Experimental Drug Development and Discovery Center shall have the 
following purposes and objectives: 
 
(a) Ensure strategic alignment with national plans and programs to strengthen 
clinical trials with a view of improving access to innovative medicines and 
investigational products; 


(b) Promote, encourage, and engage in pharmaceutical research and clinical trials 
on investigational products; 
(c) Stimulate and underwrite scientific research and clinical studies on the safety 
and efficacy of health interventions in the prevention and treatment of diseases; 
and 
(d) Encourage and undertake the training of physicians, nurses, medical and 
laboratory technicians, pharmacists, clinical trial investigators, clinical research 
coordinators and associates, data officers, health officers, and social workers 
on the practical, scientific, and ethical conduct and implementation of clinical 
trials. 
 
Section 5. The Governing Council. –  The Experimental Drug Development and 
Discovery Center shall be governed by a Council composed of the following: 
 
(a) Chair, Secretary of the Department of Science and Technology; 
(b) Co-chair, Secretary of the Department of Health; 
(c) Members: 
a. Director-General of the Food and Drug Administration;  
b. Secretary of the Department of Finance; 
c. A representative from the Pharmaceutical & Healthcare Association of 
the Philippines; 
d. A representative from the Philippine Hospital Association; and  
e. A representative from the Philippine Clinical Research Professionals. 
 
The representatives from the Pharmaceutical & Healthcare Association of the 
Philippines, Philippine Hospital Association, and the Philippine Clinical Research 
Professionals shall have the following qualifications: 
 
(a) must be of good moral character; 
(b) must be of recognized probity and independence; 
(c) must have distinguished themselves professionally in the public, private, civic 


or academic service in the field of pharmacology; and  
(d) must have been in the active practice of their professions for at least five (5) 
years. 
 
The representatives must be chosen from at least five (5) persons for each 
position, to be recommended by the Secretary of Health, and to be appointed by the 
President for a term of three (3) years.  
 
The non ex officio members may receive honoraria in accordance with existing 
laws, rules and regulations. 
 
The Experimental Drug Development and Discovery Center and the Council shall 
be established within ninety (90) days from the enactment of this Act. 
 
Section 6. Duties and Functions of the Center and Council. – The 
Experimental Drug Development and Discovery Center and its Council shall: 
 
(a) Establish and resource regional clinical trial hubs; 
(b) Provide support for the conduct of clinical trials, including capacity building, 
technical support, funding support, and intellectual property support;  
(c) Establish incentives for the conduct of local clinical trials and the introduction 
of innovative medicines, including but not limited to expeditious regulatory 
review and approval, fiscal incentives, as may be applicable, priority review 
vouchers, and exemption from pricing intervention for innovative medicines 
and investigational products notwithstanding any prior or existing law or 
regulation to the contrary; 
(d) Ensure patient protection and benefits for participating in clinical trials; 
(e) Establish early access mechanisms for qualified patients, including online 
enrollment facilities for ongoing clinical trials and early access through 
managed entry agreements; and 
(f) Reinforce provisions on intellectual property protection, including technology 


transfers. 
 
Section 7. Regional Clinical Trial Hubs. –  The Council shall develop standards 
to classify, accredit, and designate regional clinical trial hubs under the control and 
supervision of the DOST through the PCHRD. 
 
In accordance with Section 15 of this Act, the Council shall provide in the 
implementing rules and regulations of this Act for the minimum required investigational, 
research capacities and facilities, technical, operational and personnel standards of these 
hubs, as well as the appropriate licensing and accreditation requirements and procedure 
for licensing in a timely manner. The use of Public-Private Partnership shall be allowed 
on the procurement of clinical trial infrastructure and delivery of services to improve 
access to and accelerate the discovery and development of innovative medicines. Private 
institutions may also be accredited as regional clinical trial hubs, provided they comply 
with the requirements for such accreditation. 
 
The objectives and functions of a regional clinical trial hub shall be as follows: 
 
(a) Conduct clinical trials to discover and develop innovative medicines and assess 
the safety and efficacy of investigational products and/or health interventions; 
(b) Match clinical trials and innovative medicines with patients and align clinical 
study selections and initiatives with the health needs of the population; 
(c) Undertake and support the training of physicians, nurses, medical and 
laboratory technicians, pharmacists, clinical trial investigators, clinical research 
coordinators and associates, data officers, health officers, and social workers 
on evidence-based and good practice models for the delivery of clinical trials in 
a safe and ethical manner; 
(d) Establish, as necessary, networks with both public and private facilities to 
promote patients’ access to innovative medicines and investigational products 
at reduced costs; 
(e) Adopt and promote evidence-based innovations, good practice models, ethical, 


equitable, sustainable strategies and actions across the conduct of clinical trials 
and discovery and development of innovative medicines; 
(f) Engage and collaborate with local government units, private sector, 
philanthropic 
institutions, 
advocacy 
organizations 
and 
civil 
society 
organizations to facilitate the procurement of clinical trial infrastructure and the 
conduct of clinical trials; 
(g) Promote and assist in ethical scientific research and clinical trial; and 
(h) Raise awareness on the benefits of clinical trials among the local community. 
 
Section 8. Experimental Drug Development Research Fund. – There is hereby 
created an Experimental Drug Development Fund to be used exclusively for the 
implementation of this Act, which shall be administered by the Experimental Drug 
Development and Discovery Center following existing government budgeting, accounting, 
and auditing rules and regulations, with a quarterly report to the Office of the President 
and Congress on the disbursement of such fund.  
 
The Experimental Drug Development and Discovery Center may solicit and 
receive donations which shall form part of the Experimental Drug Development Fund. 
Notwithstanding any prior or existing law or regulations to the contrary, such donations 
whether from local or foreign donors shall be exempt from income tax, donor’s tax, and 
all other taxes, fees, and charges imposed by the national government or local 
government. Likewise, fund-raising activities may be conducted by the Experimental Drug 
Development and Discovery Center, and the proceeds of which shall accrue to the 
Experimental Drug Development Fund and shall be exempt from any and all taxes, fees, 
and charges imposed by the national government or local government notwithstanding 
any prior or existing law or regulations to the contrary. 
 
 
Without prejudice to the appropriation allotted to the implementation of this Act as 
mentioned in Section 16 hereof, the Experimental Drug Development Fund may be used 
to implement the provisions and policies introduced by or pursuant to this Act. 
 


Section 9. Fiscal Incentives. – Clinical Research Organizations and Sponsors of 
local clinical trials shall be eligible to register their business activities in relation to the 
conduct of local clinical trials and/or the introduction of innovative medicines under the 
Strategic Investment Priority Plan with the Fiscal Incentives Review Board, or the 
Investment Promotion Agencies, under a delegated authority from the Fiscal Incentives 
Review Board.  
  
For the purpose of this Act, local clinical trials shall be regarded as research and 
development resulting in demonstrably significant breakthroughs in science and health 
which falls under Tier III of the Strategic Investment Priority Plan. 
  
The qualified Clinical Research Organizations and Sponsors of local clinical trials 
shall be entitled to tax incentives under Chapter II of the National Internal Revenue Code 
of 1997, as amended by Republic Act No. 10963 or the “Tax Reform for Acceleration and 
Inclusion” (TRAIN), Republic Act No. 11256, Republic Act No. 11346, Republic Act No. 
11467 and Republic Act No. 11534 or the “Corporate Recovery and Tax Incentives for 
Enterprises Act” (CREATE), subject to the conditions of availment provided therein. 
  
Section 10. Priority Review. – Subject to rules and regulations to be promulgated 
by the Department of Health, the Experimental Drug Development and Discovery Center 
may award priority review vouchers to Sponsors of a local clinical trial that shall entitle 
the holders of such vouchers to priority review of their medicines with the Health 
Technology Assessment Council and the Food and Drug Administration.  
 
Section 11. Exemption from Pricing Interventions. – An innovative medicine or 
investigational product that underwent local clinical trial shall be exempt from the 
imposition of maximum retail prices under Section 17 of Republic Act No. 9502 for a 
period of ten (10) years from the date it is issued a marketing authorization or certificate 
of product registration by the Food and Drug Administration.   
 


Section 12. Online Enrollment System. – The DOST, in coordination with the 
Council, shall create, manage, and control an online enrollment system that shall be 
accessible through the existing PNHRS website.  
  
The online enrollment system shall facilitate the engagement of patients afflicted 
with life threatening, seriously debilitating, or serious and chronic illnesses or diseases 
with the appropriate Sponsor for purposes of being enrolled in ongoing clinical trials in 
whatever stage, and to facilitate access of such patients to the relevant investigational 
products: Provided, that the Sponsor shall be responsible for the funding of the clinical 
trial.  
  
For purposes of this Section, the Sponsor shall be responsible for formulating the 
appropriate criteria to be used as basis to determine the qualification of the prospective 
participants, subject to the approval of the Council, and taking into consideration the 
following, among others:  
  
a. the purpose of the study;  
b. the nature of the medicine or investigational product subject of the study, 
including its side-effects and risks; 
c. the age and sex of the prospective participant;  
d. the type and stage of the illness or disease that he or she is afflicted with;  
e. his or her previous medical and treatment history; and  
f. other existing medical conditions. 
 
Section 13. Managed Entry Agreements. – For the purposes of this Act, the 
Department of Health and/or the Philippine Health Insurance Corporation, in consultation 
with the Council, shall promote and enter into managed entry agreements with the 
appropriate Sponsors with a view to enable early access to investigational products and 
innovative medicines that have yet to be listed in the Philippine National Formulary; 
Provided, that said managed entry agreements shall be available to qualified beneficiaries 
whether or not they are enrolled in any clinical trial: Provided, further, that the managed 


entry agreements shall have as its main objective the expedited procurement, coverage, 
or reimbursement by the government of innovative medicines and investigational 
products under a criteria to be formulated by the Department of Health.  
  
It shall be the duty of the Experimental Drug Development and Discovery Center 
to keep a record of all managed entry agreements entered pursuant to this Section, and 
to monitor the progress and implementation thereof. Such records shall be available for 
perusal by the general public in accordance with existing laws, rules, and regulations.  
 
Section 14. Philippine Biopharmaceutical Patent Pool. – The Experimental 
Drug Development and Discovery Center shall also establish a Philippine 
Biopharmaceutical Patent Pool that will coordinate with innovative pharmaceutical 
companies and interested local manufacturers towards increasing local production of 
patented medicines. Incentives for participating in the Biopharmaceutical Patent Pool 
shall also be established.  
 
Section 15. Implementing Rules and Regulations. – The Council, in 
consultation with other appropriate agencies, shall, within one hundred twenty (120) days 
from the effectivity of this Act, promulgate the rules and regulations necessary to 
effectively implement its provisions. 
 
CHAPTER 3 
MISCELLANEOUS PROVISIONS 
 
Section 
16. Appropriations. – 
The 
amount 
necessary 
for 
the 
initial 
implementation of this Act shall be charged against the current fiscal year’s appropriations 
for the Department of Science and Technology. Thereafter, such amount as may be 
necessary for the continued implementation of this Act must be included in the annual 
General Appropriations Act.   
 


Section 17. Separability Clause. – Any portion or provision of this Act that may 
be declared unconstitutional or invalid shall not have the effect of nullifying other portions 
and provisions hereof as long as such remaining portion or provision can still subsist and 
be given effect in their entirety. 
 
Section 18. Repealing Clause. – All other laws, decrees, executive orders, or 
rules and regulations contrary to or inconsistent with the provisions of this Act are hereby 
repealed or modified accordingly. 
 
Section 19. Effectivity. – This Act shall take effect fifteen (15) days after its 
publication in the Official Gazette or at least two (2) newspapers of general circulation. 
 
Approved,