SB 55 — AN ACT TO AMEND TITLE 29 OF THE DELAWARE CODE ESTABLISHING THE DELAWARE RARE DISEASE ADVISORY COUNCIL.

Poore DELAWARE& STATERep. SENATE 152nd GENERAL ASSEMBLY SENATE AMENDMENT NO.

1Griffith TOSens. SENATE BILL NO.

55Hansen, AMENDHocker, SenateHoffner, BillS. No.

55,McBride, onPettyjohn, linePinkney, 20,Sokola, byWilson; deleting “shall be established within the Department of Health and Social Services” and substituting in lieu thereof the following:

“shallReps. be established within the Office of the Lt.

Governor”.Baumbach, Bolden, Carson, K.

FURTHERJohnson, AMENDRamone SenateDELAWARE BillSTATE No.SENATE 152nd GENERAL ASSEMBLY SENATE BILL NO.

55 onAN lineACT 46TO byAMEND deletingTITLE the29 numberOF “11”THE andDELAWARE substitutingCODE inESTABLISHING lieuTHE thereofDELAWARE “14”.RARE DISEASE ADVISORY COUNCIL.

FURTHERWHEREAS, AMENDa Senaterare Billdisease, No.sometimes called an orphan disease, is defined as a disease that affects fewer than 200,000 people in the United States;

55and onWHEREAS, linethere 57are by7,000 deletingknown “fromrare adiseases hospitalaffecting inapproximately Delaware”25 andto substituting30 inmillion lieuadults thereofand children in the following:United States;

“fromand anWHEREAS, acutewhile carethe hospitalexact cause for many rare diseases remains unknown, many rare diseases are genetic in Delaware”.origin and can be linked to mutations in a single gene or in multiple genes, which can be passed down from generation to generation;

FURTHERand AMENDWHEREAS, Senatepeople Billwith No.rare diseases face many challenges, including delays in obtaining a diagnosis, misdiagnosis, shortages of medical specialists who can provide treatment, and lack of affordable access to therapies and medication used to treat rare diseases;

55and byWHEREAS, deletinga LinesDelaware-based 59advisory tocouncil 60,composed byof insertingqualified inprofessionals lieuand thereofpersons living with rare diseases could educate medical professionals, government agencies, legislators, and the following,public about rare diseases as an important public health issue and byencourage renumberingand secure funding for research for the succeedingdevelopment paragraphsof accordingly:new treatments for rare diseases.

“(9)NOW, ATHEREFORE: Delaware resident who either has a rare disease or has experience caring for a person with a rare disease.

(10)BE AIT secondENACTED DelawareBY residentTHE whoGENERAL eitherASSEMBLY hasOF aTHE rareSTATE diseaseOF orDELAWARE: has experience caring for a person with a rare disease.

(11)Section One1. administrator, or their designee, from a biopharma manufacturer, appointed by the Governor.

(12)Amend OneChapter licensed79, geneticTitle counselor,29 appointedof the Delaware Code by themaking Governor.”deletions FURTHERas AMENDshown Senateby Billstrike No.through and insertions as shown by underline as follows:

55,Subchapter byXI. adding the following after line 79:

“(g) The University of Delaware InstituteRare forDisease PublicAdvisory Administration shall staff the Council.

An(a) annualThe lineDelaware itemRare allocationDisease ofAdvisory fundingCouncil must(Council) shall be providedestablished towithin the CouncilDepartment of Health and Social Services to supportadvise the operationalLegislature servicesand carriedother outgovernment byagencies theand Universitydepartments, ofas Delaware.”appropriate, SYNOPSISon Thisthe amendmentneeds makesof theindividuals followingwith changesrare todiseases Senateliving Billin No.Delaware.

55:(b) The Council shall conduct the following activities to benefit rare disease patients in Delaware:

1) It establishes the Rare Disease Advisory Council within the Office of the Lt.

Governor instead of the Department of Health and Social Services.

CBKALW Page 1 of 23 Released:

05/31/202302/28/2023 09:1102:41 AMPM 2)(1) ItConvene amendspublic thehearings, provisionmake aboutinquiries, and solicit comments from the hospitalgeneral administratorpublic appointeein Delaware to assist the Council bywith requiringa thatlandscape or survey of the appointeeneeds beof fromrare andisease acutepatients, carecaregivers, hospitaland providers in Delaware.the state.

3)(2) ItConsult increaseswith theexperts sizeon ofrare diseases on the Council fromand 11externally, membersas needed, to 14develop members,policy byrecommendations addingto theimprove following:patient access to and quality of rare disease specialists, affordable and comprehensive health care coverage, relevant diagnostics, timely treatment, and other needed services.

a)(3) aResearch secondand Delawaremake resident,recommendations whoto eitherstate hasagencies aand rareinsurers diseasethat orprovide hasservices experienceto caringpersons forwith a personrare withdisease aon rarethe disease,impact b)of ancoverage, administratorcost-sharing, fromtiering, aor biopharmaother manufacturer,utilization andmanagement c)procedures aon licensedthe geneticprovision counselor.of treatment and care services.

4)(4) ItResearch establishesand thatidentify staffingpriorities supportrelated forto thetreatments Counciland willservices be provided byto thepersons Universitywith ofrare Delawarediseases Institutein Delaware, and develop policy recommendations that include safeguards against discrimination for Publicthese Administration.populations on such issues, including in disaster and public health emergency-related planning.

(5) Publish a list of existing, publicly accessible resources on research, diagnosis, treatment, and education relating to the rare diseases in Delaware on the Council’s website.

(6) Identify areas of unmet need for research that can inform future studies and reports by the Council.

(7) Establish resources for academic institutions, state agencies, health care professionals, and other entities to provide training to employees on rare diseases in Delaware.

(8) Identify and distribute educational resources for health care providers to foster recognition and optimize treatment of rare diseases in Delaware.

(9) Research and identify best practices to reduce health disparities and achieve health equity in the research, diagnosis, and treatment of rare disease in Delaware.

(10) Establish best practices and protocols to use during a state of emergency to aid rare disease patients.

(c) The Council is comprised of 11 members:

(1) One representative from an academic research institution in the state that receives any grant funding for rare disease research, appointed by the Governor.

(2) One member of the Delaware House of Representatives, appointed by the Speaker of the House.

(3) One member of the Delaware State Senate, appointed by the President Pro Tempore.

(4) The Secretary of the Department of Health and Social Services serving by virtue of position, or the Secretary’s designee.

(5) The Insurance Commissioner serving by virtue of position, or the Commissioner’s designee.