Pharmaceutical Medicine and Translational Clinical Research

Divya Vohora, Gursharan Singh

• Publisher: Academic Press
• Year: 2017
• Print ISBN: 9780128021033
• eBook ISBN: 9780128020982
• Topic: Medicine
• Subtopic: Pharmacology

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.- Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and- Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Section III

Pharmaceutical Law and Ethics

Outline

Chapter 9 Pharmaceutical Medicine and Law

Chapter 10 Pharmaceutical Regulations in the United States: An Overview

Chapter 11 Pharmaceutical Regulations in European Union

Chapter 12 Pharmaceutical Regulations in India

Chapter 13 Pharmaceutical Regulations for Complementary Medicine

Chapter 14 Ethical Considerations in Clinical Research

Chapter 9

Pharmaceutical Medicine and Law

Gursharan Singh, Life Sciences, SmartAnalyst India Private Limited, Gurgaon, Haryana, India

Abstract

Governments are responsible for protecting public health by assuring the safety, effectiveness, and quality of pharmaceutical products. While the pharmaceutical laws vary across jurisdictions, they are all aimed at providing a regulatory control on availability, marketing, and supply of medicines. In this era of increasing globalization in pharmaceutical industry, efforts are being made towards harmonization of pharmaceutical issues. This chapter begins with a brief description of the basic legal concepts like sources of law, the legal systems, statutes, laws, regulations, guidelines, civil versus criminal law, etc. and then provides an introductory overview of pharmaceutical laws in different geographies. Apart from pharmaceutical law, other areas of intersection of pharmaceutical medicine and law are also discussed in this chapter. These include pharmaceutical product liability, data privacy and protection, and industry codes for ethical pharmaceutical promotion and communication. Intellectual property rights are another important area of law relevant to pharmaceutical industry. However, these are discussed in detail in separate chapters.

Keywords

Basics of law; comprehensive pharmaceutical law; United States; European Union; Japan; Emerging Markets; Intellectual Property Law; Pharmaceutical Product Liability; Data Privacy; Ethical Pharmaceutical Promotion

9.1 Introduction

Pharmaceutical products differ from ordinary items of commerce as a consumer cannot independently assess their safety, efficacy, and quality. To safeguard public health, countries have approved comprehensive laws and regulations as well as established national regulatory authorities to ensure that drug registration (including research & development), manufacturing, sale, distribution, and use of pharmaceutical products are regulated appropriately and that the public has access to accurate information on medicines. Apart from safeguarding public health, another critical consideration is to safeguard the investment made by pharmaceutical companies by protecting their intellectual property. The chapter also briefly discusses the criminal and civil law relevant to pharmaceutical medicine, including pharmaceutical product liability, data privacy, and protection and industry codes for ethical pharmaceutical promotion and communication [1].

9.2 Sources of Law

The sources of law vary across countries, with greater weight placed on some sources than others. The common sources of law are [2]:

• Constitution

• Legislative Enactment—Statute

• Judicial Decisions

• Treaties

• Other sources include academic writings of legal scholars, edicts from a reigning monarch, ruler, or religious group, etc.

9.3 The Legal Systems

There are two main types of legal system in the world—Common Law and Civil law [2].

The common law or case law system is followed by former British colonies as well as the United States. This system is primarily driven by judicial decisions; written constitution or codified laws are not mandatory. There is extensive freedom of contract and generally, anything that is not expressly prohibited by law is considered to be permitted [2].

The civil law system is followed by former French, Dutch, German, Spanish, and Portuguese colonies, including much of Central and South America, Central & Eastern Europe, and East Asia. The civil law system is a codified system of law. It takes its origins from Roman law. There is generally a written constitution based on specific codes (e.g., civil code, codes covering corporate law, administrative law, tax law, and constitutional law) enshrining basic rights and duties. Only legislative enactments are considered binding for all with limited role for judge-made case law. There is limited freedom of contract and writings of legal scholars get significant weightage [2].

9.4 Statutes, Laws, Regulations, and Guidelines

Statutes are laws (or acts) enacted by legislatures (Congress/Parliament/Assembly) that govern the country or state. To become law in some countries, statute must be agreed upon by the president of a republic or granted royal assent by a monarch. To enforce law, appropriate regulatory agencies are empowered. These agencies adopt regulations which serve to fill gaps in the legislation and their implementation. The regulations help agencies carry out their duties and mission, as defined in the law. As compared to law, the regulations are easier to pass and amend depending on the current and future requirements. The regulations, once passed, carry the force of law. Guidelines differ from regulations as they do not carry the force of law. However, they are even easier to modify and represent the agencies’ current thinking on the subject. They help interpret and comply with laws and regulations [1,3].

9.5 Areas Covered by a Comprehensive Pharmaceutical Law

The aim of pharmaceutical law is to provide a regulatory control on availability, marketing, and supply of medicines. Table 9.1 provides a list of areas covered by pharmaceutical laws [1].

Table 9.1

Areas Covered by Pharmaceutical Law

S. No.	Areas
A	Control of availability and marketing
1	Drug Registration
2	National Essential Medicines List/Formulary
3	Prescription and Dispensing Authority
4	Labeling
5	Generic labeling, manufacturing, and substitution
6	Pharmacovigilance
7	Information and advertising
8	Public Education
9	Imposition of fees
10	Price control
11	Herbal medicines, medicines for clinical trials, and orphan drugs
B	Control of supply mechanisms
1	Importation of medicines
2	Exportation of medicines
3	Controls, incentives, and disincentives for local manufacture
4	Control of distribution, supply, storage, and sale

Source: Pharmaceutical legislation and regulation, http://apps.who.int/medicinedocs/documents/s19583en/s19583en.pdf; [accessed 15.01.17].

9.6 Pharmaceutical Law in US

In the US, the pharmaceutical law is covered under Title 21 of the Code of Federal Regulations. It is divided into nine volumes, three chapters, and parts 1–1499. Table 9.2 provides a brief overview of 21 CFR [4].

Table 9.2

CFR Composition

Title	Volume	Chapter	Parts	Regulatory Entity
Title 21 Food and Drugs	1	I	1–99	Food and Drug Administration, Department Of Health and Human Services
	2		100–169
	3		170–199
	4		200–299
	5		300–499
	6		500–599
	7		600–799
	8		800–1299
	9	II	1300–1399	Drug Enforcement Administration, Department of Justice
		III	1400–1499	Office of National Drug Control Policy

Source: USGPO. Electronic code of federal regulations, http://www.ecfr.gov/cgi-bin/text-idx?SID=fac36cdb8bcb4e270695294577a7ff5c&mc=true&tpl=/ecfrbrowse/Title21/21tab_...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• List of Contributors
• About the Editors
• Foreword
• Preface
• Section I: Overview of Pharmaceutical Medicine
• Section II: Drug Discovery and Development
• Section III: Pharmaceutical Law and Ethics
• Section IV: Pharmaceutical Industry and Intellectual Property Rights
• Section V: Generics, Supergenerics, Biologics, biosimilars, and biobetters
• Section VI: Medical Services
• Section VII: Pharmacovigilance
• Section VIII: Drug utilization and Pharmacoeconomics
• Index