Republic of the Philippines CONGRESS OF THE PHILIPPINES Metro Manila Sixteenth Congress Third Regular Session
Begun and held in Metro Manila, on Monday, the twenty-seventh day of July, two thousand fifteen. REPUBLIC ACT No !"#$# AN ACT PRO%ULGATING A CO%PREHENSI&E POLIC' IN A((RESSING THE NEE(S OF PERSONS )ITH RARE (ISEASE
Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled: ARTICLE I GENERAL PRO&ISIONS SECTION ! Short Title. — This ct shall be !no"n as the #Rare $iseases ct of the Philippines%& SECTION * Declaration of Policy. — 't is the policy of the State to protect and promote the right to health of the people( including the right of persons suffering from rare diseases to survival and full and healthy development as individuals through access to timely health information and ade)uate medical care& 'n pursuit of such policy( the State shall institutionali*e a system that is comprehensive( integrative and sustainable and "ill facilitate collaboration among government and nongovernment agencies and organi*ations at the national and local levels( private sector( professional health organi*ations( academic institutions( communities and families to"ards the provision of early and sustainable care of persons afflicted "ith rare disease& The
State recogni*es the crucial role of research in defining health programs and activities to address the needs of patients "ith rare disease& The State also recogni*es that an effective public education program is vital in helping ensure the early diagnosis and treatment of rare disorders and in preventing those afflicted "ith them from being the sub+ect of ridicule and stigmati*ation& SECTION + Obectives. — The ob+ectives of this ct are as follo"s:
,a- 'mprove the access of patients diagnosed to have a rare disease or patients highly suspected of having a rare disease to comprehensive medical care( including drugs and other healthcare products to treat or other"ise( as "ell as timely health information to help them cope "ith their condition by:
,.- /stablishing a comprehensive and sustainable healthcare system integrated "ithin the public healthcare delivery system for early and sustainable care for patients suffering from rare diseases0 ,1- /stablishing and maintaining the Rare $isease Registry "hich shall include data on rare diseases in the Philippines( patients afflicted "ith rare diseases( and orphan drugs and orphan products& This data shall be utili*ed in formulating policies( identifying program interventions and designing researches to address the needs of patients "ith rare disease0 ,2- 'ntegrating public educational and information campaigns in the current programs of the $epartment of Health ,$3H- to identify persons afflicted "ith rare disease and help the public understand the special needs of such persons0 and ,4- 5acilitating the regular collaborative activities among sta!eholders regarding the reali*ation of the ob+ectives of this ct& ,b- Provide regulatory and fiscal incentives to support research and development studies on rare diseases and to facilitate the manufacture and importation of affordable orphan drugs and orphan products& ARTICLE II (EFINITION OF TER%S SECTION $ Definitions. — 5or the purpose of this ct( the follo"ing terms shall be defined as follo"s:
,a- Commercial use refers to the selling of orphan drugs at profit& ,b- Healthcare Practitioner refers to any doctor of medicine( dentist( nurse( mid"ife( allied health professional and other healthcare professional duly licensed by the Professional Regulatory Commission& ,c- Healthcare institutions refer to hospitals( health infirmaries( health centers( lying6in centers or puericulture centers( "hether public or private& ,d- Medical care refers to a comprehensive and professional care that encompasses correct diagnosis( treatment and prevention of rare diseases& ,e- Medical food refers to special mil! formula devoid of offending amino acids( organic acids or fatty acids( amino acid supplements( essential amino acid mi7tures( amino acid gels or +uices( and lo" protein food products that are part of the regimen for the medical treatment of patients "ith inherited metabolic diseases&
,f- Medical specialist refers to a pediatrician for patients *ero to eighteen ,86.9- years old or adult physician for above eighteen ,.9- years old ade)uately trained by e7perts in the field of inherited metabolic diseases to diagnose and treat patients "ith rare diseases& ,g- ational Comprehensive e"born Screening System refers to the e"born Screening ,BS- system established in Republic ct o& ;199 that includes( but is not limited to: ,i- education of relevant sta!eholders0 ,ii- collection( transport( biochemical screening( and reporting on result of blood samples ta!en from ne"borns0 ,iii- trac!ing and confirmatory testing to ensure the accuracy of screening results0 ,iv- clinical evaluation and biochemistryroup ,R$T=>- refers to the $3H designated pool of e7perts on rare diseases( "hich shall include e7perts from the 'H( tas!ed "ith identifying rare diseases( orphan drugs and orphan products&
,o- Telegenetics Referral System refers to telehealth using a computer net"or! system that provides remote genetic clinical consultations to physicians in the provinces for their patients& ARTICLE III I(ENTIFICATION, REFERRAL, %ANAGE%ENT AN( REGISTRATION OF PERSONS )ITH RARE (ISEASE SECTION - !dentification of Persons with "are Disease. — The $3H( in coordination "ith the 'H( shall create a Rare $isease Registry& 't shall endeavor to comply "ith set global standards( if applicable& ll patients diagnosed "ith rare disease shall be included in this registry& SECTION . "eferral of Patients with "are Disease. — Patients highly suspected of( or diagnosed "ith( rare disease shall be referred to a ne"born screening continuity clinic identified by the $3H as referral centers for treatment of rare diseases under the ational Comprehensive e"born Screening System& 5or patients from remote areas( the Telegenetics Referral System "ill be utili*ed& SECTION # #vailability of S$ecialist for the Manage%ent of Persons with "are Disease. — The $3H( "ith the assistance of the 'H( shall develop a system to train a sufficient number of
medical specialists to diagnose and manage persons "ith rare disease& SECTION / Manage%ent of Persons with "are Disease. — The $3H( "ith the assistance of the 'H( shall provide persons "ith rare disease better access to a support system through the creation of a Rare $isease Management Program under the ational Center for $isease Prevention and Control of the $3H& SECTION 0 "egistration of Persons with "are Disease. — ll healthcare practitioners and health institutions shall be re)uired to report to the Rare $isease Registry diagnosed cases of rare disease and provide reports on the status of patients: Provided( That such reports shall be sub+ect to guidelines issued by the 'H to protect the privacy of patients "ith rare disease& ARTICLE I& PERSONS )ITH RARE (ISEASE AS PERSONS )ITH (ISABILITIES 1P)(s2 SECTION !" Designation of Persons with "are Disease as Persons with Disabilities &P'Ds(. — Persons "ith rare disease shall be considered as persons "ith disabilities ,P=$s-( in accordance "ith Republic ct o& ?1??( as amended( or the Magna Carta for $isabled Persons& SECTION !! "ights and Privileges of Persons with "are Disease. — The appropriate national government agency shall ensure that they are accorded the same rights and privileges as P=$s( to "it:
,a- The $epartment of Social =elfare and $evelopment ,$S=$- shall provide assistance to persons "ith rare disease to ensure that their social "elfare and benefits provided
under Republic ct o& ?1??( as amended( or the Magna Carta for $isabled Persons( are granted0 and ,b- The $epartment of @abor and /mployment ,$3@/- shall adopt programs that promote the availability of opportunities for "or! and employment of able6persons "ith rare disease& ARTICLE & (ESIGNATION OF RARE (ISEASE, ORPHAN (RUG, AN( ORPHAN PRO(UCT STATUS SECTION !* The Rare $isease Technical =or!ing >roup ,R$T=>-& — The $3H shall convene the R$T=> "hich shall have the follo"ing roles and responsibilities:
,a- $etermine "hat disorder or disease shall be considered as a rare disease( and "hat are the orphan drugs and orphan products( and update the list periodically0 ,b- 5ormulate policies that shall regulate the approval and certification of orphan drugs and orphan products0 and ,c- /stablish a system to ensure the regular updating of information( diagnosis and treatment of rare diseases in order to provide for the comprehensive healthcare of these patients& SECTION !+ Designation of "are Disease. — The $3H( upon recommendation of the R$T=>( shall have the authority to designate any disease that is recogni*ed to rarely afflict the population of the country as a rare disease& SECTION !$ Designation of Or$han Drug. — The $3H( motu proprio or upon application by any interested person( and "ith the recommendation of the R$T=>( may designate any drug or medicine indicated for use by patients afflicted "ith any of the rare diseases as an orphan drug& =ithin one hundred t"enty ,.18- days from the effectivity of this ct( the $3H shall publish a list of orphan drugs for these rare diseases& SECTION !- Designation of Or$han Product. — The $3H( motu proprio or upon application by any interested person( and "ith the recommendation of the R$T=>( may designate any healthcare or nutritional product( other than a drug or medicine( including( but not limited to( diagnostic !its( medical devices and biological products( used primarily to prevent( diagnose( or alleviate the symptoms of rare diseases as an orphan product& =ithin one hundred t"enty ,.18days from the effectivity of this ct( the $3H shall publish a list of orphan products for these rare diseases&)avv$hi) SECTION !. Per%it for "estricted *se of an Or$han Drug+Or$han Product. — ny person may import any orphan drug
$3H dministrative 3rder o& 4( series of .;;1( and any future guidelines that may be issued on the same& =ithin thirty ,28- days from receipt of the re)uirements( the 5$ shall issue a permit for restricted use of an orphan drug
,a- /stablish the R$T=> as defined m Section 4,n-0 ,b- Coordinate "ith the 'H for the technical assistance in the implementation of this ct0 ,c- Coordinate "ith all government and nongovernment agencies that are involved in the implementation of this ct0 ,d- Support the activities of the ne"born screening continuity clinics and designate referral centers in strategic locations in the country for the timely and sustainable medical management of persons "ith rare disease0 ,e- 3rgani*e a pool of medical specialists "ho "ill be responsible in the diagnosis and management of persons afflicted "ith rare disease and their families0 ,f- =ith the assistance of the 'H and other government agencies( professional societies and nongovernment organi*ations( conduct culturally sensitive public educational and information campaigns on the nature of rare diseases( identify persons "ith rare disease and help the general public understand the special needs of afflicted persons and their right against ridicule and discrimination0 ,g- $evelop the implementing rules and regulations for the implementation of this ct "ithin one hundred eighty ,.98- days from the enactment of this ct0 and ,h- llot budget for the implementation of this ct& SECTION !/ Other !%$le%enting #gencies. — The 5$( 'H( $epartment of the 'nterior and @ocal >overnment ,$'@>-( $epartment of /ducation ,$ep/$-( $S=$( $3@/( $epartment of Science and Technology ,$3ST-( and other relevant government agencies shall have the follo"ing tas!s:
,a- 5$ shall ensure that medical foods( orphan drugs and orphan products are permitted in the country for purposes of treating rare diseases and shall develop a system that addresses emergency cases( as they may arise0 ,b- 'H shall provide technical assistance to the $3H in the implementation of this ct0 ,c- $'@>( $ep/$( $S=$ and $3@/ shall ensure that persons "ith rare disease are given the opportunity to be productive members of society and that they are given the same rights and benefits as P=$s0 ,d- $3ST shall provide mechanisms to further research for a better understanding of rare diseases in the country and develop lo" cost medical foods and orphan products for the patients0 and ,e- ll other relevant government agencies shall assist in the full implementation of this ct& SECTION !0 Obligation of ealthcare Practitioners. — healthcare practitioner "ho attends to a person "ith rare disease has the responsibility of informing the patient and their family of available resources and refer them to the nearest available specialist& SECTION *" ontinuing /ducation and Training of ealth Personnel. — The $3H and the 'H( together "ith health professional societies and academic healthcare institutions( shall:
,a- Conduct continuing education( information( and training programs for healthcare practitioners on the identification and referral of persons "ith rare disease for medical management0 and ,b- /ducate healthcare practitioners on the importance of reporting cases to the Rare $isease Registry& ARTICLE &II RESOURCE GENERATION AN( FISCAL INCENTI&ES SECTION *! 5inancial ssistance for Persons "ith Rare $isease& — person "ith rare disease may avail of the follo"ing:
,a- Basic benefit pac!age from the Philippine Health 'nsurance Corporation( "hich shall be provided in accordance "ith its guidelines0 and ,b- Medical assistance as provided in Section 9 of Republic ct o& .82. or the Sin Ta7 Reform ct of 18.1& SECTION ** 5iscal 'ncentives& A The follo"ing shall be e7empted from all ta7es and customs duties( as applicable( "hether national or local:
,a- $onations intended for researches on rare diseases( maintenance of the Rare $isease Registry( or for purchase of orphan drugs or orphan products for use solely by patients "ith rare diseases0 and ,b- 3rphan drugs and orphan products for use solely by patients "ith rare diseases( as certified by the 5$& ARTICLE &III FINAL PRO&ISIONS SECTION *+ !%$le%enting "ules and "egulations &!""(. — =ithin one hundred eighty ,.98days from the effectivity of this ct( the $3H( in consultation "ith the 'H( shall issue the 'RR of this ct& SECTION *$ "e$ealing lause. — ll general and special la"s( decrees( e7ecutive orders( proclamations and administrative regulations( or any part or parts thereof( "hich are inconsistent "ith this ct are hereby repealed or modified accordingly& SECTION *- Se$arability lause. — 'f( for any reason or reasons( any part or provision of this ct shall be declared or held to be unconstitutional or invalid( other parts or provisions hereof
"hich are not affected thereby shall continue to be in full force and effect& SECTION *. /ffectivity. — This ct shall ta!e effect fifteen ,.- days after its publication in at least t"o ,1- ne"spapers of general circulation&
pproved( ,Sgd&- FELICIANO BEL%ONTE 3R Spea!er of the House of Representatives
,Sgd&- FRAN4LIN % (RILON President of the Senate
Senate Bill o& 1;;8( "hich "as approved by the Senate on $ecember .4( 18.( "as adopted as an amendment to House Bill o& ;?2 on $ecember .( 18.& ,Sgd&- %ARIL'N B BARUA5'AP Secretary >eneral House of Representatives pproved: MR 82 18. ,Sgd&- BENIGNO S A6UINO, III President of the Philippines
,Sgd&- OSCAR G 'ABES Secretary of the Senate
