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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Good Distribution Practices may be implemented in India for pharmaceutical products soon
India’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for pharmaceutical products should be made mandatory soon. The DCC is of the view that there is a gap in the law which requires owners of premises such as warehouses to ensure appropriate storage condition for drugs, but no such requirement exists for transporters who transport the drugs, and this affects the quality of drugs.
Source: bit.ly/49cMPCk

TB vaccine clinical trials begins in India
A Hyderabad based biotechnology company has started Phase 3 clinical trials of tuberculosis (TB) vaccine called MTBVAC among the adults in India. The vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from human strain, unlike the BCG vaccine.
Source: bit.ly/495Zuak

Medical and Sales Representatives’ body says new Pharma Marketing Code lacks teeth
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI) has criticized the newly notified Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), describing it as a futile effort. It stated that the new code lacks statutory enforcement and contains no explicit penal provisions against unethical marketing by pharmaceutical and medical device companies.
Source: bit.ly/495ZAic

Fire safety in hospitals should be evaluated by Government before Summer Season: Disaster Management Body
India’s Union Health Ministry and National Disaster Management Authority (NDMA) have jointly issued an advisory to all States and Union Territories (UT’s) to take proactive measures to check fire safety compliance of all hospitals before the incoming summer season.
Source: bit.ly/4akq9Bg

No change in surrender value norms for life insurance policies: Insurance Regulator
The Insurance Regulatory and Development Authority of India (IRDAI) has decided to retain the current surrender value requirements for life insurance policies due to concerns over higher surrender value expressed by the industry. Surrender value in life insurance is an amount paid by the insurer to the policyholder when the policy is terminated prior to the policy’s maturity date.
Source: bit.ly/43zOkcL

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UCPMP 2024 – Highlights and Summary of Key Differences from UCPMP 2015

India’s Department of Pharmaceuticals (DoP) has published The Uniform Code For Pharmaceutical Marketing Practices, 2024 (UCPMP 2024). The UCPMP is a code that governs the interaction between the industry and healthcare practitioners (HCPs/doctors) in India. The UCPMP 2024 replaces the UCPMP 2015, and is applicable to both pharma and medical device companies.

In the paragraphs below, we have summarized the business-critical changes between UCPMP 2024 and UCPMP 2015.  The expression ‘company’ refers to both pharma and medical device companies, unless the context suggests otherwise.

Enforceability: The UCPMP 2024 is ‘kind of’ ‘somewhat’ mandatory. The text of UCPMP 2024 does not carry the word ‘voluntary’ as UCPMP 2015 did, but at the same time, it also does not have any statutory backing. It appears that the DoP is planning to enforce it through ‘audit’ mechanism. Under UCPMP 2024, DoP has the power to order an audit of any company upon receipt of a complaint of violation of UCPMP 2024 against the company. In case the audit proves a breach, the DoP may ‘recommend’ appropriate government agencies (such as the Income Tax Department and the National Pharmaceutical Pricing Authority) to take action against the company. An appellate body, which is headed by the Secretary, DoP, also has the power to ‘prescribe’ penalties to defaulting companies. Separately, the CEO of the company has to give an undertaking that the company shall abide by UCPMP 2024 will extend all assistance to ‘authorities’ for its enforcement.

Medical Education and Training: Companies can sponsor or organize conferences, workshops and trainings for doctors by themselves without having to necessarily collaborate with another entity, such as an association of doctors. Such conferences, workshops and trainings cannot be held outside India. The details of such events and expenses incurred by the company will have to be published on the company’s website. The record of these expenses may be audited by auditors appointed by the DoP. If the DoP auditors find discrepancies in the records, they will bring them to the attention of appropriate government agencies and authorities.

Hospitality and travel: During conferences and workshops, all doctors including delegates may be served modest meals. However, delegates cannot be offered travel facilities. Speakers may be offered both hospitality and travel facility.

Brand reminders: A company may supply doctors with informational and educational materials such as e-journals and dummy device models as brand reminders, provided that the total worth of each item does not exceed Rs. 1000. There is no cap on how many brand reminders can be given to the doctor. However, a brand reminder should not have an independent commercial value for the doctor.

Engagement of HCPs as a Consultant: Companies can continue to engage doctors as consultants for research, but the research has to be ‘bona fide’. The DoP is expected to provide more clarity on this issue.

Monetary grants: Companies cannot offer monetary grants under any pretext now, including for educational purposes to doctors who are pursuing training, residency, or fellowship.

Sample packs: A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.

Further changes to UCPMP 2024: The DoP has reserved powers to modify or limit the scope of UCPMP by issuing standing orders from time to time.

It is important that industry takes cognizance of the changes because any non-compliance with UCPMP 2024 may negatively impact a company’s industry standing and perception amongst doctors.  India’s tax department has also been disallowing any expenses which have been incurred in contravention of UCPMP, so a mistake may prove very expensive.

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: Government
The Secretary, Department of Pharmaceuticals, has reportedly said that the government will appoint a panel of auditors who can undertake risk-based audits from time to time, to evaluate whether the promotional expenses, especially towards conferences and workshops, have been incurred in an ethical manner as per the Uniform Code for Pharmaceutical Marketing Practices 2024. Any discrepancy will be reported to the appropriate government agency or authority.
Source: bit.ly/49SNs5f

Industry welcomes the new Uniform Code for Pharmaceutical Marketing Practices
The pharmaceutical industry has reportedly welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP). According to news reports, the industry feels that the new code is a step ahead towards the advancement of the industry as it ensures ethical and healthy engagement between the pharmaceutical industry and medical professionals.
Source: bit.ly/4a6SZWd

Nutraceutical and food supplement regulations are to be tightened further
The Food Safety and Standards Authority of India (FSSAI) is in the process of tightening the regulations for nutraceuticals and health supplements. This move was prompted by the receipt of several complaints by the FSSAI about the presence of non-compliant health supplements on the market and the fact that the over-the-counter availability of nutraceuticals and health supplements is resulting in people consuming supplements along with drugs, which increases the risk of adverse effects.
Source: bit.ly/3wXMsOU

A major e-commerce entity was fined Rs 25 lakh due to its inaction to remove counterfeit products from the marketplace
A State Consumer Commission in India has imposed a fine of Rs. 25 lakhs on a major e-commerce entity on the grounds that the e-commerce entity failed to correct the listing of a product, which it was aware was a counterfeit product. By failing to remove the listing, the Commission held that the e-commerce entity had engaged in dark patterns and unjust enrichment.
Source: bit.ly/3IBUsaH

EU to extend regulatory data protection for innovator drugs to 7.5 years
The European Union is set to extend regulatory data protection for innovator drugs to 7.5 years, with one extra year of incentives if the drug meets an unmet medical need and clinical trials are conducted in the EU. There is a proposal to grant an additional 3 years of protection from generics, taking the total protection to a maximum of 11.5 years.
Source: bit.ly/3IxEIWl

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Ethical marketing and promotion of medicines

Time and again, the pharmaceutical industry has been accused of indulging in unethical practices concerning the marketing of medicines around the world.  These unethical marketing practices are, in fact, a major area of concern for the Government as well as patient groups. Amongst all unethical practices, the one that attracts the highest amount of scrutiny is the (questionable) interaction between pharmaceutical companies and healthcare practitioners (HCPs).

India is no exception. The Draft Pharmaceutical Policy, 2017 published by the Government itself makes a note that unethical practices employed by pharma companies are an area of major concern and that Doctors are lured to recommend a particular brand through all expenses paid trips often disguised as ‘educational conventions’. Unfortunately, the cost of such trips and other incentives gets added to the overhead cost of marketing of the medicine and is ultimately passed on to the patients.

There is no law at present that regulates the promotion and marketing of drugs (including medical devices) by companies before HCPs. Interactions between pharma companies and HCPs are regulated, at best, by way of restrictions cast on HCPs through their respective professional and ethical guidelines. For example, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 regulate the professional and ethical conduct of doctors practising modern medicine and prohibits doctors from accepting any kind of freebies (including travel and accommodation) from pharma and allied healthcare industry. Unfortunately, the principal legislation that regulates the pharma industry i.e. The Drugs and Cosmetics Act, 1940 does not say what pharma companies can and cannot say, or give or cannot give, to HCPs.

It is true that there are consumer protection legislations in India such as the Consumer Protection Act, 1986 (now the Consumer Protection Act, 2019) and the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules, 1955 but these legislations regulate misleading advertisements, not unethical industry-HCP interaction.

It is, perhaps, not right to say that the government has turned a blind eye to this problem. In fact, in light of the increasing number of complaints of unethical practices adopted by pharma companies, the Department of Pharmaceuticals had introduced the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) back in 2011 (later revised in 2014). The intent behind UCPMP code was to guide the pharma industry in its interaction with HCPs. However, the voluntary nature of UCPMP has relegated its own status to that of a “non-binding guideline”.

However, not all is lost. There is no dearth of pharma companies who are proudly ethical in their dealings with HCPs. In fact, most pharma MNCs have put in place exhaustive internal guidelines and robust internal systems which guide interactions of their medical representatives/marketing personnel with HCPs.  Interestingly, HCPs also seem to value such ethical behaviour. It is obvious that, at the end of the day, a HCP will prescribe medicines from only those pharma companies whose quality he or she trusts.

It is quite likely that the Indian government may decide to give legal teeth to UCPMP and make it binding. After all, the UCPMP is the nearest Indian equivalent to the US Physicians Payment Sunshine Act that we have. Interestingly, the enforcement of the Sunshine Act by US Authorities have resulted in hundreds of millions of dollars in fines for some pharma companies.

There is no doubt that making UCPMP into a law would certainly help to curb the rampant quid-pro-quo arrangements that exist today between pharma companies and HCPs. More so, those companies which currently engage in unethical practices will be forced to re-evaluate their sales and marketing strategies and become compliant, or else they will have to face legal consequences.  

In the meanwhile, at least those companies who have achieved leadership positions in India’s pharma industry may lead by example and assume voluntary responsibility to follow UCPMP in text and spirit. The pharma industry associations would also do much good if they could adopt the UCPMP and direct their members to ensure compliance with the provisions of UCPMP at all costs. Such proactiveness will go a long way in instilling a sense of confidence amongst the Government and patients groups. And if that happens, needless to say,  the heavily regulated industry that is pharma industry will have one less regulation to worry about.

The views are personal.

Anil Upadhyay