Legal Protection of Drug Insert Sheet
By Bai Fan
Updated: 2015-09-11

Nowadays, the issue of whether drug specification or drug insert sheet should be protected by copyright law has once again attracted public attention because of different attitudes adopted by different courts in China in judicial practices. Many questions have arisen from such practices, which are worth of concern and discussion, including: does such a sheet constitute a copyrightable subject matter? If not, is it necessary to give it other types of legal protection, and how? Solutions to theses questions will not only be conducive to the theoretical clarification of the legal status and feature of such sheets, but also be helpful to the regulation of drug manufacturer in terms of business behavior and maintenance of legitimate rights and interests.

I. Copyright Analysis of Drug Insert Sheet

(i) Possible Originality

Copyrightability of the drug insert hinges on whether it is a “work” within the meaning of the Copyright Law. Rule 2 of Regulations for the Implementation of Copyright Law of the People’s Republic of China defines copyrightable work as “work(s) shall mean original intellectual achievements in the literary, artistic, and scientific domains that can be reproduced in a tangible form”, Wherein we only need to be concerned about the originality of the insert. By generally accepted standard, originality means independent creation, which requires that the work be created by, and originated from, with minimum level of intellectual creation to show the author’s personal judgment and selection. Here, we may further narrow down the scope for discussion: whether the composition of the insert conforms to the requirement, by focusing on whether the content of the insert can reach the level of creation required for a copyrightable “work”.

It is the view of this author that the originality and independent intellectual creation contained in the insert can be divided into two aspects, namely, “what to write” and “how to write”; the former refers to the selection, acceptance or rejection, organization and arrangement of optional items and all materials, and the latter, the particular expression thereof.

In terms of “what to write”, some scholars believe that although product specification “is a kind of objective reflection of the machine’s functions and structure, how to express the machine’s functions, structure and parameters is still a reflection of the author’s acceptance or rejection, selection, organization and design”, from which the originality can be found. The author fully agrees with this view. However, one thing should be noted is that the precondition for the application of this view is that there are items for the author to freely “accept, reject, select, arrange and design”, which means that the author has a relatively greater room for free creation.

In respect of “how to write”, there are three kinds of works, namely, literary, artistic and scientific works according to Article 1 of China’s Copyright Law, which further defines in its article 3 that “work(s)” mentioned in this Law include work(s) of literature, art, natural science, social science, engineering technology, […]”, wherein the works of “natural science, social science, engineering technology, etc.” are scientific works, which describe contents of science and technology, and elaborate the author’s thoughts and views in this regard. However, the drug insert intends to make an introduction of the product’s composition, operation theory, methods of application, precautions, etc., which is a kind of expository essay in style, and should be undoubtedly attributed to scientific works in content. Generally speaking, language is used in scientific works in a more rigorous, objective, concise and direct way than in non-scientific works. Therefore, there is smaller creative room for drug inserts than that for the general literature works because of the limitation on writing style and length of specification. Of course, this does not mean that drug inserts have no originality in its specific language expression. Due to the limited creativity, such originality may be possibly expressed in the writer’s special selection and arrangement of items, particularly under the condition of very limited means of expression for the concrete words.

(ii) Copyright Law Does Not Preclude Protection of Drug Inserts

One view disfavoring protection of drug inserts holds that since drug inserts need to be approved by China Food and Drug Administration (CFDA), they are annexes to the drug authorities’ “drug approval”, and an inseparable part of the drug permit. As the promulgator and issuer, CFDA has the authority to modify it. Therefore, a drug insert has the color of official documentation of administrative nature. Under Article 5(1) of the Copyright Law, such documentation is not subject to copyright protection, and therefore, drug inserts are not protectable under the Copyright Law. The author does not agree with this view.

According to Article 2(4) of Berne Convention, it shall be a matter for legislation in the countries of the Union to determine the protection to be granted to official texts of a legislative, administrative and legal nature, and to official translations of such texts. However, the convention and its Guideline make no definition of official administrative texts. Even so, the author thinks that, according to the principles of administrative law and copyright law, it may be the condition that such official texts should be works of the administrative organ as legal person because the texts are created by the administrative organ as president who makes the texts a reflection of its will and takes responsibility as a result. It seems from such point of view that drug insert is far from administrative texts even if it needs to be approved by drug administration. Firstly, copyright law has a general rule on ownership of copyright that copyright shall be owned by the person who creates it, and no approval is required for copyright. Secondly, whether drug insert sheet can be approved shall be decided by drug and food administration according to law and the enterprise may modify the sheet according to the requirement of administrative organ. However, it can not be thought that the sheet is a reflection of the will of administrative organ under such circumstance. In fact, such modification is a show of legal requirement instead of a request of a specific organ, and offering consulting advice shall not be considered a creation according to Article 3(2) of Regulations for the Implementation of Copyright Law of the People’s Republic of China. China’s Provisions on the Administration of Pharmaceutical Directions and Labels provides in its Article 12 that “a drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely. China Food and Drug Administration may also require a drug manufacturer to make modification to the insert sheet on the basis of the results of adverse drug reaction monitoring and drug re-evaluation”, from which the author can conclude that the subject to modify drug insert sheet is the drug manufacturer. Thirdly, the insert shall be released separately or together with product in the name of the enterprise instead of administrative organs. Finally, administrative organ can be exempted from responsibility under the pretext of its only role in formal examination of sheet content in the event of error(s) in drug insert sheet, and the manufacturer shall be responsible for such error(s).

It can be seen from the above that the subject for the responsibility of drug insert sheet is the enterprise engaged in research and production of drug instead of administrative organ or its staff because drug administrative organs are just the subject in charge of examination but approval of drug insert sheet and not the subject in charge of composition or modification of such sheet. Furthermore, the fundamental purpose for the composition of drug insert sheet is to guide the doctor and patient for medication to meet the needs of public health other than for service in administrative management, and on the contrary, administrative function of drug administrative organ is to serve the public health in the end. Therefore, it is not opportune to take drug insert sheet as administrative texts.

II. Limitation on the Composition of Drug Insert Sheet

Although a common specification can be deemed as copyrightable work, it should be noted that law and the principle of copyright law in particular has stipulated many multiple limitations on drug insert sheet, which narrows the room for free creation to huge extent and may result in impossibility of access to copyright. The author would like to discuss such limitations as follows.

(i) Limitation on format. China has made clear stipulations on the items that should be contained in drug insert sheet in its Pharmaceutical Administration Law, Provisions for Drug Insert Sheets and Labels, Regulations for Package Inserts of Chemical Drugs and Biological Products and other laws and regulations. For example, Pharmaceutical Administration Law provides in Article 54(2) that “in the label or insert sheet shall be indicated the adopted name of the drug in China, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, adverse drug reactions, and precautions”. The confine of such items for composition sets a limitation on the room for creation, and in particular, makes it difficult for the writer to make his selection, acceptance or rejection and arrangement in terms of such items, and the sheet has thus very little chance to be original in terms of materials selection and texture arrangement.

(ii) Limitation on words usage. As mentioned above, the language used in drug insert sheet must be rigorous, concise and easy to understand because of limitation on its attribute, purpose, length, etc., which sets limitation on its style and expression. Meanwhile, some items in specification, such as description or composition, usage, adverse drug reactions and symptoms, should use standardized words and expression. Provisions for Drug Insert Sheets and Labels provides in Article 10 that “disease names, pharmaceutical terms, drug names, the names and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards”. Other contents also have many commonly used word usage and relative fixed expression methods. There is a basic requirement that the wording in drug insert sheet must be standardized, accurate and concise, and the sheet tends to use common language in order to meet such requirements.

(iii) Limitations on examination and approval. Drug insert sheet needs to be examined and approved by China State Food and Drug Administration, which will decide the drug’s marketing time and directly influence the enterprise’s economic interest. The examination and approval by the drug administration not only excludes the possible novelty in sheet, but also makes the enterprise more cautious and law-abiding in order to go through the examination and approval procedure smoothly and quickly, due to which the enterprise usually follows the common format, projects, terminology and expression methods, which may even be the target for sheet writer to the best. Therefore, most of drug insert sheet seems stereotyped and has no originality at all.

(iv) Limitations from the principle of copyright law. In addition to “compulsory items” required by the laws, some drug insert sheets have to contain a number of “optional items”, such as instructions for drug’s interactions, pharmacology, drug poisoning, etc., and the description of process of testing on animal or human, data and result, which may be the last straw for drug insert sheet to be deemed as work under copyright law. It seems that the author still has difficulty to make a choice in terms of such items, and the judge of whether such texts falling within the protection of copyright law needs an introduction of a basic principle of copyright law, namely, no fact shall be protected by copyright law. Copyright law grants no protection for simple description of facts in order to prevent the obligee from monopolizing facts and ideas, and there shall be no protection for expression where an idea has only one or several kinds of expression methods. This exclusion principle is known as “hybrid principle”. As mentioned above, drug insert sheet usually tends to be concise because of the limitation on style, due to which the description of testing process, data and result are so simple and single that it is sufficient to be deemed as pure and mere facts or to be applied by the “hybrid principle”. It should be emphasized that the fact that although the experimental results and data are original and experimental enterprises may also invest a lot of money in such experiment, has no influence on the question whether the writer’s description should be protected by copyright law. What copyright law concerns about is nothing but originality, and abolition of the doctrine of “sweat of the brow” and no protection for data without originality under China’s current Copyright Law are just good evidence of the practice. Originality in experiment and capital in investment offers no help to the access of concrete expression to the originality under copyright law. And such protection should be excluded where there is a possibility of mixture of ideas with expression and of monopoly in pure and mere facts.

III. Possible Approaches for Protection

There is very limited room for the creativeness of compulsory items and it is also true for the same kind of drug, whereas the optional items, such as the description of testing process, data and result are the facts that are not protected by copyright law. Therefore, the author supports the idea that those sheets in line with the requirements of Copyright Law be protected by Copyright Law and it should be judged in concrete case, and that common drug insert sheet can not be protected by copyright law because it is difficult for it to have originality.

It should also be noted that it will be unfair if the law refuses to grant protection for drug insert sheet and allows others to plagiarize. That’s because on the one hand, enterprise has often made efforts to invest human resource, materials and funds in drug experiment in order to have a relatively objective experimental data in line with relevant standard and requirement, and that the law should, on the other hand, give a negative evaluation by its role in value guidance because simple plagiari sm of other’ s experimental result will greatly harm the experimental purpose, drug experiment result will directly influence consumer’s life and health, and every time of experiment of the same kind of drug is just a process of mutual authentication to identify problems and to discard the false and retain the true.

Meanwhile, the author thinks that an enterprise may have the following advantages in competition by such plagiarism. First, cost saving. An enterprise that chooses to plagiarize other than to make experiment can save human resource and funds which should have been invested in experiment. As a result, the enterprise can increase its input in other fields and improve its competitiveness. Second, time saving. A relatively long period of time is needed to go through the process from experiment to examination and approval. An enterprise by plagiarism, may make its drug insert sheet go through the whole process in a shorter period, so that its product can be sold on the market in advance to its competitors in order to seize market share. Third, enhancing attractiveness. Any words and marks with implied therapeutic effects, misleading information on usage or inappropriately promoting the product shall not be printed. However, an experimental result that is real and can prove the function of the product is the best publicization, and a drug insert sheet with such content can effectively win more attraction. Indeed, an enterprise may get benefits from plagiarism to have an advantage in competition. However, such advantage is getting something for nothing by unfair exploitation of other’s fruit, and such means of competition is obviously in violation of the standard and rule for market competition and business ethics and morals.

IV. Conclusion

To sum up, the author holds that it is necessary to grant protection for experimental data contained in drug insert sheet on one hand; and that there is culpability in the sense of law in some enterprises’ pursuit of competitive advantage through unfair means on the other hand; and that both sides need to be adjusted by law. Under such circumstance, there should be application of general articles of China’s Anti-unfair Competition Law to grant protection for other enterprises’ experimental data and set counter-measures on certain enterprises’ unfair competition. It should be noted that an enterprise may be required to submit evidence from its actual experiment against the asserted plagiarism because the same referential items may be selected for the same kind of drug in the same experimental process, and hence, the experimental result may be the same or the alike, and such requirement will not be an unreasonable burden on the enterprise concerned.

Legal Protection of Drug Insert Sheet

(Translated by Yuan Renhui)

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