- When I use a word . . ...
- When I use a word . . . The languages of medicines—trade names, proprietary names, or brand-names
Opinion BMJ 2024; 385 doi: https://doi.org/10.1136/bmj.q1206 (Published 31 May 2024) Cite this as: BMJ 2024;385:q1206
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- Jeffrey K Aronson
- Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Follow Jeffrey on X (formerly Twitter): @JKAronson
Individual medicines have both chemical names and generic names, such as British Approved Names (BANs) and International Nonproprietary names (INNs). Medicinal products are often referred to by the generic names of their active ingredients. However, a medicinal product, which contains inactive as well as active ingredients, can also have a proprietary name, also known as a trade name or brand name. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on what is and is not acceptable in the formulation of such proprietary names.
Naming medicines
As I have previously outlined,1 a medicine can have up to four types of names, distinguishing what a medicine or its name is from what the medicine or its name is called:
● name 1—what the medicine is, as indicated by its full chemical name;
● name 2—what the medicine’s name is, i.e. its generic name, as assigned in a specific country, such as a British Approved Name, or by the World Health Organization, its International Nonproprietary Name (INN);
● name 3—what the medicine’s name is called, i.e. any brand-names assigned by a pharmaceutical company;
● name 4—what the medicine itself is called, i.e. colloquial names given to it by the general public, such as street names for recreational drugs and drugs of abuse.
Individual medicines have both chemical names and generic names, such as British Approved Names (BANs) and International Nonproprietary names (INNs). Medicinal products are often referred to by the generic names of their active ingredients. However, a medicinal product, which contains inactive as well as active ingredients, can also have a brand name, specific to that product.
I have previously discussed chemical names2 and generic names,3 including British Approved Names4 and International Nonproprietary Names (INNs).5 Now it’s the turn of the brand-names, also known as trade names or proprietary names.
Trade name
This is the earliest of the three terms. In its earliest use it dates from 1821, when it was used, in the words of the Oxford English Dictionary (OED), to refer to “a name by which a thing or person is called in the specialist vocabulary (or jargon) of a particular trade or occupation.”6 Examples given in the dictionary include “bosh,” a trade name given to mixed or adulterated butter (1858); “stem,” a banana (1905); and “demographics,” used to describe, for example, the composition of a television audience (1970).
Later, the term came to mean “the name under which a business operates,” attested from 1840. For example, “The University of Oxford” is the registered international trade name (technically a trademark) of that institution, and the owner of the name is Oxford Limited.7
At about the same time, the term “trademark” came into use, defined as “a mark (typically a word, phrase, logo, or symbol, or a combination of these elements) which is legally registered or has been established by use as representing a person or company, and applied to products, packaging, etc., in order to distinguish the owner's products and services from those of others.”8
However, it was not until 1890 that the term “trade name” was used to mean what it is generally regarded as meaning today, “the name assigned to a product or service by its manufacturer or provider, typically having the status of a trademark.” In other words, a legally registered trade name is one form of trademark.
Proprietary name
This is the term that is most commonly used in official documents that refer to the brand names that manufacturers give to their medicinal products. The term is defined in the OED as “a word or phrase over which a person or company has some legal rights, esp. in connection with trade”9 and it dates from 1898.
The word “proprietary” derives from a classical Latin adjective, proprius, which means one’s own absolutely or in perpetuity, and a derived noun, proprietarius, an owner or proprietor. The relevant definition of “proprietary” in the OED is “of a product, esp[ecially] a drug or medicine: of which the manufacture or sale is restricted to a particular person or persons; (in later use) spec[ifically] marketed under and protected by patent or registered trademark.”10
The earliest recorded instance of this meaning is to be found in the 1785 Medicine Duties Act c. 79, a Stamp Act that was promulgated during the reign of King George III, in which the definition of medicinal preparations covered was extended to try to encompass medicines that did not have a Royal Letters Patent, while being advertised as such.11 The text in Section 4 reads “Mixtures, compositions, or preparations ... are not, nor hereafter shall be ... exposed to sale ... by written or printed papers or hand bills, held out or recommended to the publick by the makers, proprietors, or vendors thereof, as nostrums or proprietary medicines, or as specifics.”
Brand-name
This is the most recent coinage, from 1922, and is simply defined in the OED as “a trade or proprietary name.”12 The word comes from an old Teutonic root meaning to burn, as in the operation of marking cattle with one’s brand.
Guidance
There are regulatory guidelines, which lay out desiderata governing a manufacturer’s choice of a proprietary name for a medicinal product. The Medicines and Healthcare products Regulatory Agency (MHRA) published UK guidance in 201913 and the US Food and Drug Administration (FDA) did so in 2020.14 Here I shall describe the former.
Introduction
In the introduction to the document, the three components of the name of a medicinal product are described: the name itself, the strength of the formulation, and the type of formulation. Together these three elements should be stated in that order at the start of the Summary of Product Characteristics (SmPC), but each part is regarded as a separate entity. This implies that the proprietary name should not contain anything that reflects either of the other two components.
Two other items in the introduction deal with the right of the Licensing Authority to reject a name and the continued responsibility of the manufacturer for the safety of the product after approval.
Legal requirements
Some of the criteria that regulate proprietary names have the formal backing of legislation. A European Directive (2001/83/EC) requires that a proprietary name should not be likely to be confused with the generic name of the drug or with the name of any other medicinal product. Nor should a proprietary name include features that might suggest (a) beneficial effects of the product; proven or claimed, (b) specific ingredients in its composition, or (c) anything that relates to its purported safety.
Real words
Although it is not stated first in the guidance, a primary criterion is that a proprietary name should not itself be a “real word, i.e. have a meaning.” The guidance does not specify how that should be judged. For example, a particular dictionary is not specified. Nor is it laid down that, for example, foreign words, which might be obscure, or, say, the names of fictional characters, are inadmissible. The use of such coinages is certainly possible, although unlikely. However, new words are being coined all the time, and it is conceivable that a new coinage might be adopted, either unchanged or with slight modification. What has certainly happened in the past is the converse—the entry of a proprietary name into the language as a “real word,” a process that has been labelled genericization. Aspirin is the classic example; it started life as a proprietary name for acetylsalicylic acid and has come to be used as the common name for that compound, often sold under other proprietary names.15 Aspirin is unusual in not having a generic name. Other examples, outside pharmacology, have included Elastoplast, Escalator, Hoover, Sellotape, Taser, Xerox, and in the USA, Band-Aid and Kleenex. There is nothing a manufacturer can do about this, since it depends on public usage, particularly when the word is merely spoken. Attempts to protect proprietary names that have suffered this fate have generally been unsuccessful.
Other criteria
Although the MHRA’s guidance contains a range of recommended restrictions that are not specifically covered in law, a name, if considered unsatisfactory, may be rejected by the Licensing Authority, and these recommendations therefore have something of the force of law.
For example, anything that implies potency of any sort should be avoided; this includes words such as “forte” or “strong.”
The population for whom the product is designed, the formulation, the strength, and the route of administration should not be indicated in the name.
Terms suggesting speed of action should also be avoided. These include terms such as “Fast acting” and “Express” or “Xpress.”
Other terms are listed that may occasionally be used for specific purposes, and which need specific justification in individual cases. These include “Advance,” “Extra” or “Xtra,” “Maximum strength,” “One-a-day,” “Original,” “Plus” and “Triple action,” even though these are, for the most part, “real words.”
Qualifiers
Certain terms are sometimes used to describe properties of a formulation, and the guidance describes the circ*mstances in which such qualifiers are acceptable. Among them, numerals, either Arabic or Roman, and single letters should not be used.
The abbreviation “MR,” for modified-release, which has been used in the past to describe a range of formulations that have been manipulated in order to control the rate at which a drug is released from a product after administration, is now not acceptable. The term was originally introduced as a unifying term to indicate the wide range of all such formulations, but it is now recommended that more specific abbreviations be used to describe the mechanism involved. For example, CR for controlled release, LA for long acting, and SR for sustained release. I am puzzled by the implication that these terms are distinct from one another. For example, controlled-release technologies can result in long-acting products,16 as can sustained-release technologies.17 However, pharmaceutical chemists presumably understand the nuances.
Similar guidance is given about the use of the abbreviations EC (enteric coated) and GR (gastro resistant).
Non-prescription medicines
Since non-prescription medicines are intended to be chosen for use by individuals independent of medical advice, the names of such medicines may include information about indications, for example “Bloggs Pain Relief Tablets.” They may not, however, imply misleading suggestions, such as “Bloggs Head Pain Away Tablets.”
Rejection and responsibility
If on the advice of the MHRA, or on their own assessment, the Licensing Authority considers that a proprietary name is unacceptable for any reason, they may reject a name.
Conversely, acceptance of a proprietary name does not relieve the manufacturer of the responsibility for taking action if hazards are revealed or harms occur.
A proviso
My summary of the MHRA’s guidance on proprietary names contains my own interpretation of the guidance and should not be regarded as a definitive version. For that, the original guidance should be consulted.13
Footnotes
Competing interests: JKA chairs The British Pharmacopoeia Commission’s Expert Advisory Group on Pharmacy and Nomenclature and is a member of the WHO’s Expert Advisory Panel on International Pharmacopoeia and Pharmaceutical Preparations.
Provenance: not commissioned; not peer reviewed.
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