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Pharmaceutical law regulates the creation, sale, distribution, and use of medicines. It covers intellectual property, public policy, and national regulation, and involves government lawyers, corporate lawyers, and personal injury lawyers. The law protects drugmakers’ research through patents and sets rules on generic equivalents. Governments establish safety and testing requirements before drugs can be sold or prescribed, and regulate drug marketing and prescribing. Pharmaceutical lawyers must have extensive knowledge of the industry, and their work can involve influencing policy, enforcing laws, protecting patents, and handling personal injury cases.
The creation, sale, distribution and use of medicines are strictly regulated in most countries. Laws protect drugmakers’ research by granting patents on methods and set rules on how and when generic equivalents can enter the market. Governments typically also establish safety and testing requirements before allowing drugs to be sold or prescribed. Other laws control how drugs can be marketed, both to prospective patients and physicians, and physicians’ prescribing abilities are also often shaped by regulations. The intersection of these laws and all other laws related to the pharmaceutical industry creates what is known as the pharmaceutical law.
In many ways, the field of pharmaceutical law is an intersection of intellectual property, public policy, and national regulation. On the one hand, pharmaceutical manufacturers need protection for all the research that goes into the creation of a drug. This typically comes in the form of a patent, which is an intellectual property tool. On the other hand there is consumer protection. If a product is entering the free market as a pharmaceutical drug, governments typically want certain assurances that the product is safe. The government also has an interest in ensuring that the drug is properly advertised and, in most cases, only dispensed by qualified doctors to diagnose problems.
A pharmaceutical lawyer generally must have extensive knowledge of the pharmaceutical industry to be successful in practicing pharmaceutical law. Despite the breadth of the field, however, the actual work of most pharmaceutical lawyers is quite concentrated. Lawyers usually work for the government, a drug manufacturer, or injured consumers. The contours of each job are markedly different, although each is an aspect of pharmaceutical law.
Some lawyers work to influence pharmaceutical policy from the top. These attorneys typically work for government entities and help create rules for drug testing requirements, safety inspections, and advertising regulations. Licensing requirements and oversight of pharmacists also often come into play. Government lawyers are typically responsible for enforcing national pharmaceutical laws, which means they punish drug companies, pharmacies, and doctors who violate the laws.
Companies typically rely on legal counsel to handle a variety of internal pharmaceutical law issues. The primary job of a corporate pharmaceutical lawyer is usually patent protection. Patents are very important to pharmaceutical manufacturers. If a competing manufacturer can simply wait for a drug to hit the market, then imitate it, the imitated product can usually be sold at a much cheaper price because the competing manufacturer hasn’t had to invest as much capital in research and development. Patents can cover not only the process by which a drug was made, but also proprietary blends of ingredients and, in some cases, percentages of ingredients.
Pharmaceutical patents are generally issued only for limited durations as established by law. After a while, contestants can attempt to recreate the drug. The presence on the market of equivalents of generic drugs occurs after the patent of a drug has expired. All of this is controlled by the pharmaceutical law.
The practice of pharmaceutical law also incorporates elements of personal injury and pharmaceutical ethics. If a patient is harmed by the use of a drug that perhaps should have been better tested or better labeled, the patient may choose to file a lawsuit against the manufacturer. These types of lawsuits typically involve large classes of plaintiffs and involve the application of pharmaceutical law to real-life situations. Basically any case involving pharmaceutical drugs falls within the scope of pharmaceutical law, whether it concerns how the drugs were manufactured, how they were used or how they were dispensed.
