알기쉬운 보건의료 산업정책 제1권

서문 / 3

추천사 / 10

제1장 보건의료산업의 개념

1. 보건의료산업의 범위 ·················································································· 29

2. 제약?의료기기산업의 역사 ········································································ 32

3. 보건의료산업의 산업적 중요성 ································································ 38

4. 보건의료산업의 분류 ················································································· 42

제2장 제약산업

제1절 제약산업의 정의와 범위 ·································································· 45

1. 제약산업의 정의 ························································································· 45

2. 제약산업의 범위 ························································································· 47

3. 제약산업의 특성 ························································································· 48

4. 제약기업의 종류와 특성 ··········································································· 52

제2절 제약산업의 국내?외 시장 현황 ······················································ 54

1. 제약산업의 세계시장 ·················································································· 54

2. 제약산업의 국내시장 ·················································································· 61

제3절 의약품의 종류 ·················································································· 79

1. 의약품의 정의 ····························································································· 79

2. 일반의약품과 전문의약품 ·········································································· 80

3. 안전상비의약품 ··························································································· 82

4. 의약외품 ······································································································ 82

5. 혁신적 의약품과 자료제출 의약품 ·························································· 82

6. 처방의약품과 OTC 의약품 ······································································· 83

7. 완제의약품과 원료의약품 ·········································································· 83

8. 신약과 생물학적제제 ················································································· 84

9. 화합물신약과 바이오신약 ·········································································· 85

10. 개량신약과 바이오베터 ············································································ 86

11. 제너릭과 바이오시밀러 ············································································ 87

12. 대조약 ········································································································ 88

13. 세포배양의약품 ························································································· 88

14. 천연물신약 ································································································ 88

15. 화합물의약품의 종류 ··············································································· 90

16. 디지털 신약 ······························································································ 93

제4절 바이오의약품 ···················································································· 97

1. 바이오의약품의 정의 ·················································································· 97

2. 바이오의약품과 재생의료 ········································································ 100

3. 세포치료제 ································································································ 109

4. 유전자치료제 ····························································································· 120

5. 표적 항암제와 면역 항암제 ···································································· 126

6. DNA백신 ··································································································· 133

7. 인체 유래 생물학적 치료제 ···································································· 135

8. 장기 칩 ······································································································ 136

9. 식물세포 재조합 단백질 ·········································································· 136

10. 마이크로바이옴(세균치료제) ································································· 142

제5절 의약품의 특징과 분류 ··································································· 145

1. 의약품의 특징 ··························································································· 145

2. 외국의 의약품 분류 ················································································· 149

제6절 의약품 개발 과정 ·········································································· 150

1. 후보물질 발굴 ··························································································· 150

2. 의약품 개발연구 ······················································································· 151

3. 상용화 ········································································································ 178

제7절 건강보험 약가 제도 ······································································· 206

1. 요양 급여 ·································································································· 206

2. 비급여 ······································································································· 207

3. 요양 급여비용의 산정 ············································································· 208

4. 약제의 요양급여비용 산정 ····································································· 209

5. 의약품 건강보험 등재제도 ······································································ 210

6. 약가 결정 및 조정 ··················································································· 215

7. 약가 우대 정책 ························································································· 218

8. 건강보험 약제비 증가 원인 ···································································· 219

제8절 의약품 유통 ···················································································· 224

1. 의약품 리베이트 방지 ············································································· 226

2. 의약품 경쟁질서 형성 및 유지 ······························································ 229

3. 이 밖의 의약품 유통관리 ······································································· 234

제9절 백신산업 ························································································· 252

1. 백신의 종류와 특징 ················································································· 252

2. 세계 백신산업 현황 ················································································· 257

3. 국내 백신산업 현황 ················································································· 259

4. 백신산업의 핵심 현안 ············································································· 262

제3장 의료기기산업

제1절 의료기기의 정의와 분류 ······························································· 267

1. 의료기기의 정의 ······················································································· 267

2. 의료기기의 분류 ······················································································ 268

3. 의료기기의 특성 ······················································································· 273

제2절 의료기기산업의 범위와 특성 ························································ 275

1. 의료기기산업의 분류 ················································································ 275

2. 의료기기산업의 특성 ··············································································· 276

제3절 의료기기산업의 국내?외 시장 현황 ············································· 278

1. 의료기기산업의 세계시장 ········································································ 278

2. 의료기기산업의 국내시장 현황 ······························································ 292

제4절 의료기기 개발 과정 ······································································· 310

1. 의료기기 연구개발 과정 ·········································································· 310

2. 의료기기에 활용되는 주요 기술 ····························································· 311

제5절 주요 의료기기 개발 기술 ····························································· 315

1. 마이크로 의료로봇 ···················································································· 315

2. 치매 등 스마트케어용 의료기기 ···························································· 329

3. 임상수요 기반 의료기기 개발 ································································ 333

4. 환자 맞춤형 정밀의료기기 개발 ···························································· 338

5. 질환극복 진단?치료기기 개발 ································································ 342

6. 스마트 융복합 환자 케어 시스템 ·························································· 347

7. 지능형 치과진단 및 보철치료 통합솔루션 ··········································· 349

8. 초저선량 스마트 X-선 의료영상기기 ·················································· 350

9. 지능형 인체삽입형 헬스케어 기기 ························································ 352

10. 스마트 진단 치료 통합 솔루션 ···························································· 354

11. 인공지능 기반 로봇 융합 의료기기 ····················································· 355

제6절 의료기기 임상시험과 품목 인허가 ··············································· 358

1. 의료기기 제조 및 품질관리기준 적합성 인정 ······································ 358

2. 의료기기 임상시험 ··················································································· 359

3. 품목 인허가 ······························································································ 361

제7절 신의료기술 평가 ············································································ 372

1. 신의료기술 평가 대상 및 절차 ······························································ 373

2. 신의료기술의 안전성?유효성 평가 ························································ 376

3. 제한적 의료기술 평가제도 ······································································ 376

4. 신의료기술 평가 유예제도 ····································································· 376

제8절 건강보험 급여 제도 ······································································· 378

1. 신의료기술에 대한 건강보험 급여 ························································· 379

2. 행위조정 신청과 기존 기술의 판단 ······················································ 379

3. 치료재료의 수가 책정 ············································································· 379

4. 치료재료 가치평가제도 ············································································ 381

제4장 보건의료산업 정책의 이론적 배경

제1절 산업정책론 ······················································································ 385

1. 산업정책의 역사 ······················································································· 385

2. 산업정책의 정의 ······················································································· 387

3. 산업정책의 4가지 요소 ··········································································· 390

4. 산업정책의 특성 ······················································································ 392

5. 산업정책의 수단 ······················································································· 395

6. 우리나라 제약산업 지원정책 ··································································· 411

7. 의료기기산업 지원정책 ·········································································· 414

8. 산업정책의 유형 ······················································································· 418

9. 산업정책과 무역정책의 차이점 ······························································ 422

10. 산업정책의 목표 ····················································································· 424

11. 산업정책에서 정부개입의 근거 ····························································· 425

12. 산업정책과 국제통상 규범 ···································································· 426

13. 4차 산업혁명과 일자리 ········································································· 426

14. 기술 혁신과 산업 고용효과 ·································································· 437

15. 산업 혁신 ································································································ 440

16. 기업 인수합병과 전략적 제휴 ······························································ 443

17. 산업정책의 성과평가 ············································································· 446

제2절 정책론 ····························································································· 448

1. 정책의 정의 ······························································································ 448

2. 정책의 4가지 구성요소 ··········································································· 450

3. 정책의 분류 ······························································································ 452

4. 6단계 정책결정 과정 ·············································································· 455

5. 정책결정 모형 ·························································································· 465

6. 정책 집행 ·································································································· 470

7. 정책 평가와 변동 ····················································································· 472

8. 정책 형성과 정책 과정 ··········································································· 475

9. 정책의 분석 ······························································································ 478

10. 정책 참여자 ···························································································· 479

제3절 행정론 ····························································································· 483

1. 행정의 정의 ······························································································ 483

2. 행정의 특성 ······························································································ 484

3. 현 시대에서 행정의 특징 ······································································· 487

4. 행정의 기술성과 과학성 ········································································· 488

5. 7가지 행정이념 ························································································ 489

6. 행정의 내부적 외부적 환경 ··································································· 494

제4절 행정법 ····························································································· 497

1. 행정법의 정의 ··························································································· 497

2. 법치주의와 법치행정 ··············································································· 498

3. 행정의 성문법적 법원 ············································································· 499

4. 행정의 불문법적 법원 ············································································· 501

제5절 규제론 ····························································································· 507

1. 규제의 정의 ······························································································· 507

2. 정부규제의 개념과 효과 ·········································································· 513

3. 정부규제의 적용원칙 ··············································································· 514

4. 경제규제 ···································································································· 515

5. 사회규제 ···································································································· 520

6. 사법규제 ···································································································· 523

제6절 지식재산권 ······················································································ 526

1. 지식재산권의 종류 ··················································································· 526

2. 지식재산권의 특성 ··················································································· 527

3. 지식재산권의 보호 ··················································································· 528

4. 지식재산권의 제한 ··················································································· 530

5. 의약품 특허 ······························································································· 531

6. 무역 관련 지적재산권 협정 ··································································· 538

제7절 국제통상론 ······················································································ 540

1. 산업정책과 국제통상의 연관성 ······························································ 540

2. WTO 보조금 협정 위반 판단기준 ························································ 543

3. 금지 보조금과 허용 보조금의 유형 ······················································ 547

4. 상계조치 ···································································································· 553

5. GATT의 내국민 대우 의무 ···································································· 555

제8절 연구개발론 ······················································································ 557

1. 연구개발의 범위 ······················································································· 557

2. 연구개발의 단계 구분 ············································································· 560

3. 연구개발 현황 ··························································································· 561

4. 연구개발의 역사 ······················································································· 575

5. 연구개발의 성과 ······················································································· 581

6. 국가연구개발사업의 기획?평가?관리 ···················································· 585

7. 연구개발사업과 연구윤리 ········································································ 592

8. 보건복지부 연구개발 사업 ····································································· 598

제9절 경제적 정책적 타당성 분석 ·························································· 602

1. 타당성 분석의 목적 ················································································· 602

2. 경제적 타당성 분석 ················································································· 602

3. 정책적 타당성 분석 ················································································· 609

제5장 보건의료산업별 주요 정책

제1절 보건의료산업의 정책 ····································································· 617

제2절 제약산업 육성 정책 ······································································· 621

1. 제약산업 정책에서 고려해야 할 점 ······················································· 621

2. 제약산업 정책과 관련되는 환경 변화 ·················································· 623

3. 제약산업의 핵심 현안 ············································································· 627

4. 제약산업 육성 기본방향 ········································································· 638

5. 제2차 제약산업 5개년 종합계획의 비전과 목표 ································· 648

6. 제약산업 육성 추진전략 및 실천과제 ·················································· 649

7. 신약 개발 역량 제고를 위한 R&D 강화 ············································· 650

8. 중소?벤처 기업의 신약 개발 생태계 구축 ··········································· 655

9. 제약바이오 분야의 전문인력 양성 ························································ 659

10. 우리나라 제약산업 브랜드 가치 제고 ················································· 652

11. 제약산업 육성을 위한 제도개선 지원 ················································· 667

12. 백신산업 육성 ························································································· 673

제3절 의료기기산업 육성 정책 ······························································· 681

1. 의료기기산업 정책에서 고려해야 할 점 ················································ 681

2. 의료기기산업 정책과 관련되는 환경 변화 ··········································· 682

3. 의료기기산업의 핵심 현안 ····································································· 684

4. 의료기기산업 육성 기본방향 ·································································· 689

5. 의료기기산업 5개년 종합발전계획의 비전과 목표 ····························· 690

6. 의료기기산업 육성 추진전략 및 실천과제 ··········································· 691

7. 미래 유망 의료기기 기술개발 연구개발 확대 ······································ 691

8. 의료기기 기업 역량 강화 및 국내?외 시장진출 지원 ························ 694

9. 의료기기산업 육성 및 시장 진입을 위한 제도 개선 ·························· 698

참고문헌 ····································································································· 703

찾아보기 ····································································································· 709