Republic of the Philippines 
House of Representatives 
Quezon City, Metro Manila 
Twentieth Congress 
First Regular Session 
HOUSE BILL NO. 4259 
Introduced by Representatives Ferdinand Martin G. Romualdez, Yedda 
Marie K. Romualdez, Andrew Julian K. Romualdez and Jude A. Acidre 
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%1of Filipinos 
believing that the government should have a greater role in affordable and 
comprehensive medicine 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 
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] 
September 1, 2025
3:49 pm


2 
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. 
FERDINAND MARTIN G. ROMUALDEZ 
YEDDA MARIE K. ROMUALDEZ 
ANDREW JULIAN K. ROMUALDEZ 
JUDE A. ACIDRE 
2 FDA Circular No. 2012-007 
3Citeline, 20 May 2020. Number of New Clinical trials per year, Southeast Asia, 2000-2019 
4IQVIA. 2019. Access to Innovation. 


Republic of the Philippines 
House of Representatives 
Quezon City, Metro Manila 
Twentieth Congress 
First Regular Session 
HOUSE BILL NO. 4259 
Introduced by Representatives Ferdinand Martin G. Romualdez, Yedda 
Marie K. Romualdez, Andrew Julian K. Romualdez and Jude A. Acidre 
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.” 
SEC. 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 


2 
 
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. 
 
SEC. 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. 
 


3 
 
(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; 


4 
 
 
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 


5 
 
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 
 
SEC. 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; 
 


6 
 
(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. 
 
SEC. 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  
 


7 
 
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. 
 


8 
 
SEC. 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. 
 
SEC. 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. 


9 
 
 
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; 


10 
 
 
(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. 
 
SEC. 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 


11 
 
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. 
 
SEC. 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 


12 
 
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. 
  
SEC. 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.  
 
SEC. 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.   
 
SEC. 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 


13 
 
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. 
 
SEC. 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 


14 
 
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.  
 
SEC. 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.  
 
SEC. 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 
 
SEC. 16. Appropriations. – The amount necessary for the initial implementation 
of this Act shall be charged against the current fiscal year’s appropriations for the 


15 
 
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.   
 
SEC. 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. 
 
SEC. 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. 
 
SEC. 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,