Filing a Provisional Patent in California: Your Complete Guide
November 11, 2024
Covid19 home testing kits provide a simple way for users and pharma companies are actively marketing such kits. Recently, the market got flooded with over-the-counter home tests for covid-19. In the US, there are three companies behind the launch of home testing kits for covid19. On one hand, such kits provide an easy mechanism to conduct fast covid19 tests at home that are cheaper, whereas on the other hand, such kits may result in errors during covid19 screening. There are some stakeholders who consider using these kits for mass screening of public for covi19 wherein such mass screening tests can be repeated regularly. The three main companies selling these kits in the US market are BinaxNOW by Abbott, Lucira Check-it, and, Ellume Covid19 Home Test.
Pharmaceutical companies are increasingly making use of different marketing tactics and ideas in order to promote their pharmaceutical products. For Pharma products marketing, it is essential to make maximum use of different types of media, both offline and online. Pharma products marketing helps in raising the brand value of a particular brand by creating an identity, by way of Pharma advertising and promotion.
Physician Marketing is basically using to market various pharmaceutical products like formulations, vaccines, antibiotics, medicines, blood, hormonal supplements, inhalation devices, intra-pleural pumps, nutrition, vitamins etc. Some of the common promotional ideas used by Pharma products marketing companies include giving away free samples, free trials, free products, by email marketing, participating in various forums, participating in teleseminars, etc. Besides these there are several other Pharma products marketing tools like brochures, flyers, website advertisements, business cards, logo embossing, etc.
Pharmaceutical companies generally use more than one promotional approach in order to promote their pharmaceutical products. By making use of all these promotional tools and ideas a company can significantly raise its brand visibility. There are several pharmaceutical companies who are focusing more on promotional marketing as a source of increasing the sales of their products.
The Pharma industry is seeing a significant growth and most of the leading companies are seeing a substantial increase in sales. Most of these companies are utilizing this form of advertisement to expand their customer base and thereby improving their profitability. Therefore, we can say that the pharmaceutical industry is going to see a lot of growth in the coming years and so it is important for all the manufacturers and suppliers to adopt the right measures of promoting their products through promotional tools.
Pharmaceutical Industries all over the world take part in fierce drug publicity, to improve the prescribing habits of doctors and to motivate self-medication amongst patients. Extensively, drug advertising denotes the informative and influential actions of the pharmaceutical industries, the impact of which is to persuade medication, supply, trade, and usage of therapeutic drugs. The pharmaceutical industry has the freedom to nurture its commodities and drugs, but it must accomplish this in a fair, accurate, and ethical way. The promotional assertions must be credible, honest, enlightening, harmonious, up-to-date, and competent of substantiation in good taste. Regardless, today whilst the promotional techniques have become very intricate and beneficial, it was established that while endorsing their commodities, the pharmaceutical industries do not embrace these ethical regulations. Thus, in most circumstances, these lead to unfair usage of drugs. This sad circumstance can be handled solely through the multiple-prong method about government, pharmaceutical industries, physicians, medical institutes, and customers. The government is expected to develop some procedures in extension to formulating their laws. The physicians and patients are compelled to be informed of the promotional strategies and misuses perpetrated by the pharmaceutical industries and various ways to deal with those. Different medical and patient associations must also mediate to enhance the strategy of advertising.
On 26th April 2020, the world celebrated World Intellectual Property Day. On this occasion, Dr. David Nabarro, an envoy to WHO on COVID-19, sent out a video message that brought focus on the importance of strengthening and bettering intellectual property rights. This is particularly important when it is thought about in the context of medical supplies which are essential. The strengthening of Intellectual Property Rights poses as an advantage when trying to combat problems of counterfeit medical supplies such as face mask, medical equipment and unfortunately, even medication.
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA) has distinguished that Advertising encompasses “any note, brochure, brand, wrapper or another article, and any testimony rendered verbally or by any means of generating or transmitting light, noise or smoke”. Further, the Code for Self-Regulation of Advertising content in India (CSRA) characterizes Advertising as a “paid-for transmission, expressed to the world or a portion of it, the objective of which is to influence the impressions or demeanor of those to whom it is expressed. Any transmission which in its natural course would be understood as advertising by people would be incorporated in this description, even if it is carried free-of-charge”.
Pharmaceutical Promotion
The OPPI Code for Pharmaceutical Practices 2019 (OCPPI) establishes that Promotion includes “any action performed, founded or endorsed by a partner company which is directed at healthcare experts and specialists to facilitate the medication, proposals, allowance, management or consumption of its pharmaceutical commodity through all outlets, encompassing the internet, SMS, social media, etc.”.
India does not have a distinct law that governs the advertisement and promotion of drugs and medical equipment by businesses before Health Care Practitioners (HCPs). Advertising drugs and medical equipment to customers, on the other hand, is considerably controlled. The Central Government had released a set of protocols in 2014 called the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) as recommendations for the industry for advertising and trading drugs and medical equipment. Nonetheless, these policies are can only be followed willingly and do not have the force of law. The government is considering a different code for the promotion of medical equipment called the Uniform Code for Medical Device Marketing Practices (UCMDMP), which is yet been finalized. Until UCMDMP is legally enforced, the UCPMP must be dealt with as the official recommendation for the promotion of medical tools by such companies.
Legal Framework for Pharmaceutical Products
As seen in all countries and jurisdictions, India also tries to guarantee that reliable marketing policies are pursued by pharmaceutical and medical businesses when endorsing their commodities to healthcare professionals. While the limitations on influencing healthcare specialists are not as limited as those for direct-to-consumer advertising, there are few common protocols that advertisers are expected to obey. The DMRA is the main statute that regulates the promotion of medicines and medical tools in India. The DMRA pertains to both advertisements formulated for the general populace as well as healthcare specialists. As a corollary to the above-mentioned regulations, there are limitations on healthcare specialists under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 against receiving gifts, travel capacities, hospitality, cash and monetary authorizations from pharmaceutical and medical equipment factories, and suppliers. Further, the advertisement and promotion of medicines in India are regulated by the following:
1. The Drugs and Cosmetics Act,1940 and the Drugs and Cosmetics Rules 1945
2. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Drugs and Magic Remedies Rules 1955
3. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002
4. The Pharmacy Practice Regulations 2015
5. The Sales Promotion Employees (Conditions of Service) Act 1976
6. The Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”), a voluntary code.
7. The Code for Self-Regulation of Advertising content in India, published by the Advertising Standards Council of India
8. The OPPI Code for Pharmaceutical Practices 2019, drafted and published by the Organization for Pharmaceutical Producers of India. The OCPP is relevant only for OPPI member businesses, which generally grow to be foreign international pharmaceutical enterprises functioning in India.
Essential Commodities (Control of Unethical Practices in the Marketing of Drugs) Order, 2017
Several recent reports have demonstrated that the Central Government is speculating the introduction of Essential Commodities (Control of Unethical Practices in the Marketing of Drugs) Order, 2017 that would supervise advertisement and promotions of pharmaceutical drugs by pharmaceutical corporations before the HCPs. An interesting characteristic of the Order is that it will be regulated, unlike UCPMP which is a suggestive document. It is endorsed to be announced under the Essential Commodities Act, 1955. The EC Act governs the output, allotment, distribution, exchange, and business of essential commodities. All medicines and supervised medical tools are observed as essential commodities in India. As EC Act is a public interest law, it is enforced in an extremely strict manner. The Courts have also exhibited hesitation in intervening in the enactment of orders published under the EC where laws had the capability of influencing companies negatively but were earning a larger public interest. Another important element is that, unlike UCPMP, the Draft Order will not involve the promotion of medical tools. However, it is anticipated that any prospective order related to medical tools would be designed on the Draft Order. Thus, it could be beneficial for the medical tool companies to be conscious of this expansion.
The Draft Order attempts to supervise the assertions that pharmaceutical corporations make in course of advertising, including the way the assertions are made. The assertions or claims must not be deceiving and inclined to provoke unjustifiable drug use, giving rise to undue risk. They must not be capable of substantiation and cannot use the word “safe” unless it is not suitably authorized. The Promotional material that is developed for a commodity must not disguise its real nature. The Order further monitors the commerce of pharmaceutical businesses with HCPs in terms of its proposal of free specimens except for the entire course of therapy of three clients to gain the experience of therapy. It also regulates gifts, cash card, hampers, etc. or anything which produce “monetary benefit” or authorize “gains in kind” to the HCP or its family. The prerequisite of the registration fee, travel, stay, or food in or outside India involving the attendance of a seminar, pursuing Medical Education Programmes for scientific meetings. The Draft Order envisages the institution of a fresh authority called Ethics Compliance Officer who will be given the responsibility to examine any allegation of infringement or infractions of the Order and to grant or commute penalty as is specified by the Order. The pharmaceutical corporation will be provided a chance to be heard before an order for suspension of marketing is enacted.
Advertising Standards Council of India’s Code for Self-Regulation in Advertising (ASCI Code)
The ASCI Code was drafted by the Advertising Standards Council of India (ASCI), as a willing self-regulatory agency and not a Government authority. The ASCI Code strives to supervise the subject of promotions or advertisements. This Code pertains to advertisers, agencies, social media, and others such as market research enterprises who are branches of ASCI. This Code has also been ratified by people, corporate entities, and organizations immersed in or otherwise related to the process of advertisement with the ASCI Code functioning as the basic tactic. Under the ASCI Code, the duty for its compliance lies with those who build, position, or disseminate any advertising or help in the production or publication of any promotion. Under the requirements therein, all advertisers, advertising agents, and media are required not to develop, place or disseminate any advertisement which violates the ASCI Code. The Code pertains to promotions examined, heard, or regarded in India even if they emanate or are circulated abroad so long as they are directed to customers in India or are revealed to a substantial quantity of customers in India. It may be pointed out, though, that the orders of ASCI are not enforceable through court.
Conclusion
Since the guidelines that govern the pharmaceutical world are constantly changing and developing, laws that govern such advancement must be motivated to protect end customers. This includes protecting them from false advertisements and promotions. Thus, the main takeaways for the pharmaceutical sector concerning the CUPMD Order would be to recognize its implications on its business, drugs, and medical equipment. Bad marketing exercises have frequently been a bone of contention for the Administration as well as various patient organizations. Now and then, the pharmaceutical business has been condemned for embracing questionable methods concerning the exchange of their products. The primary emphasis, thus, in this respect has been sceptical exchanges between pharmaceutical corporations and healthcare practitioners/ providers.
Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements. Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
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