Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Batasan Hills, Quezon City 
NINETEENTH CONGRESS 
Second Regular Session 
HOUSE BILL NO. 10516 
Introduced by  
HON. ATTY. GERVILLE “JINKY BITRICS” R. LUISTRO 
AN ACT TO ACCELERATE THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE 
MEDICINES BY STRENGTHENING CLINICAL TRIALS, AND FOR OTHER PURPOSES 
EXPLANATORY NOTE 
The enactment of Republic Act No. 11223, known as the Universal Health Care Act, 
underscores the government's commitment to providing all Filipinos with accessible, high-
quality, and comprehensive healthcare services. This encompasses preventive, curative, 
rehabilitative, and palliative care. An essential component of this policy is the advancement of 
clinical trials, which are recognized as a vital scientific and research-based approach that enables 
medical researchers and developers to maximize benefits, minimize risks, and ensure the safety 
and efficacy of new medications. 
Research has consistently underscored the necessity of this government policy, 
particularly as the demand for improved healthcare services among Filipinos continues to grow. 
A recent survey indicated that 96% of Filipinos believe the government should play a more 
significant role in ensuring access to affordable and comprehensive medical care. This prevailing 
public sentiment highlights the importance of bolstering government support for research and 
development initiatives aimed at enhancing healthcare services.1 
At present, clinical trial activities in the Philippines are predominantly driven by the 
private sector, with government support provided through regulatory bodies such as the 
Department of Health (DOH) and the Food and Drug Administration (FDA). Research-based 
pharmaceutical companies have historically invested substantial amounts in conducting clinical 
trials in the country, which has positioned the Philippines as a notable player in the global 
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] 
June 6, 2024
5:02 pm


clinical trial landscape.2 
However, recent trends indicate a significant decline in the number of new clinical trials 
conducted in the Philippines since 2014. This decline has widened the gap between the 
Philippines and other leading countries in the field, resulting in limited access to innovative 
medications for Filipino citizens.3 According to the Journal of the American Medical Association 
(JAMA), currently, only 1 out of 166 new medicines introduced globally is included in the 
Philippine National Formulary. This scarcity limits the availability of advanced treatments to the 
Filipino population (JAMA, 2020).4 
The situation is further exacerbated by findings published in The Lancet, which 
emphasize the crucial role of clinical trials in advancing medical knowledge and improving 
patient outcomes. The decline in clinical trials in the Philippines has contributed to a lag in the 
availability of cutting-edge treatments, adversely impacting public health (The Lancet, 2019).5 
Given this context, it is imperative to rejuvenate the Philippines' status as a regional hub 
for clinical excellence and to enhance access to groundbreaking medications. This can be 
achieved by overhauling and modernizing our clinical trial infrastructure through the 
establishment of an Experimental Drug Development and Discovery Center. This initiative is 
supported by findings from the New England Journal of Medicine (NEJM), which advocate for 
the modernization of clinical trial systems to facilitate the rapid and safe introduction of 
innovative therapies (NEJM, 2018).6 
The necessity for such an initiative is further backed by legal and jurisprudential 
foundations. The 1987 Philippine Constitution, particularly Article XIII, Section 11, which 
mandates the State to adopt an integrated and comprehensive approach to health development.7 
Additionally, jurisprudence such as the Supreme Court ruling in Pharmaceutical and 
Health Care Association of the Philippines v. Duque III (G.R. No. 173034, October 9, 2007) 
reinforces the government's obligation to ensure the availability and accessibility of essential 
medicines to the public.8 
2 FDA Circular No. 2012-007 
3 Citeline, 20 May 2020. Number of New Clinical trials per year, Southeast Asia, 2000-2019 
4 Journal of the American Medical Association (JAMA). "Global Availability of New Medicines and Impact 
on Public Health." JAMA, 2020. 
5 The Lancet. "The Importance of Clinical Trials in Advancing Medical Knowledge and Improving Patient 
Outcomes." The Lancet, 2019. 
6 New England Journal of Medicine. "Advancements in Clinical Trial Design and Strategy for Enhanced 
Drug Development." NEJM, 2018. 
7 Constitution of the Republic of the Philippines, 1987, Article XIII, Section 11. 
8 Supreme Court of the Philippines, "Pharmaceutical and Health Care Association of the Philippines v. 
Duque III," G.R. No. 173034, October 9, 2007. 


In view of the foregoing, approval of this bill is earnestly sought. 
HON. ATTY. GERVILLE “JINKY BITRICS” R. LUISTRO 


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Batasan Hills, Quezon City 
NINETEENTH CONGRESS 
Second Regular Session 
HOUSE BILL NO. 10516
Introduced by  
HON. ATTY. GERVILLE “JINKY BITRICS” R. LUISTRO 
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: 
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 
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 products), and/or to identify any adverse reactions to an investigational 
products), and/or to study absorption, distribution, metabolism, and excretion of an 
investigational products) 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), (i), (ii) 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 Ill 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 Il 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 PHRS 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 ecessary for 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,