Statements (85)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
legislation
|
| gptkbp:aimsTo |
encourage research into rare diseases
|
| gptkbp:appliesTo |
orphan drugs
|
| gptkbp:defines |
orphan_drug_as_a_medicine_for_a_rare_condition
|
| gptkbp:enactedBy |
gptkb:European_Union
|
| gptkbp:encourages |
clinical trials for rare diseases
|
| gptkbp:establishedIn |
2000
|
| gptkbp:hasImpactOn |
patient access to treatments
|
| gptkbp:hasResidence |
more orphan drug designations
|
| gptkbp:hasTheme |
increased investment in rare disease research
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU orphan drug legislation
|
| gptkbp:includes |
market exclusivity for 10 years
|
| gptkbp:isActiveIn |
academic research
|
| gptkbp:isAssociatedWith |
economic incentives
|
| gptkbp:isAttendedBy |
gptkb:European_Medicines_Agency
|
| gptkbp:isChallengedBy |
legal disputes
generic drug manufacturers |
| gptkbp:isConnectedTo |
biotechnology advancements
healthcare disparities healthcare_innovation healthcare_policy_reforms healthcare_funding_models |
| gptkbp:isCriticizedFor |
lack of transparency
inequitable access complex application processes lengthy approval processes limited patient involvement potential for abuse by companies |
| gptkbp:isDiscussedIn |
media coverage
academic journals policy papers legislative debates healthcare_conferences EU_policy_forums |
| gptkbp:isEvaluatedBy |
effectiveness
regulatory compliance regulatory bodies scientific committees economic assessments health economists impact on innovation |
| gptkbp:isFacilitatedBy |
development of new therapies
|
| gptkbp:isInfluencedBy |
scientific research
international collaborations international regulations patient advocacy groups stakeholder consultations clinical trial results |
| gptkbp:isIntegratedWith |
reduce market barriers
|
| gptkbp:isLinkedTo |
ethical considerations
patient outcomes socioeconomic factors global health initiatives public health outcomes drug development timelines healthcare_access_issues |
| gptkbp:isLocatedIn |
gptkb:EU_pediatric_regulation
|
| gptkbp:isMonitoredBy |
gptkb:European_Commission
|
| gptkbp:isPartOf |
public health policy
EU_regulatory_framework EU_health_initiatives EU_health_policy_framework EU_health_regulations EU_pharmaceutical_strategy EU_regulatory_landscape global_orphan_drug_policies |
| gptkbp:isPromotedBy |
EU_health_programs
|
| gptkbp:isPromotedThrough |
awareness campaigns
|
| gptkbp:isReflectedIn |
patient satisfaction surveys
regulatory frameworks. drug approval rates drug pricing models EU_health_statistics |
| gptkbp:isRelatedTo |
gptkb:EU_Regulation_No_141/2000
|
| gptkbp:isReviewedBy |
5 years
|
| gptkbp:isSubjectTo |
EU_law
|
| gptkbp:isSupportedBy |
clinical guidelines
government funding research funding initiatives advocacy campaigns research partnerships patient organizations EU_member_states |
| gptkbp:provides |
pharmaceutical companies
|
| gptkbp:requires |
designation of orphan status
|