What does your company do to stay ahead of new and changing regulations? Is it consistently finding new methods and sources of monitoring? Every organisation should be able to answer these questions to ensure they keep up with today’s legislative landscape. In the wake of GDPR, it’s the perfect time to reevaluate the ways you monitor regulatory changes.
Are You Prepared for Tomorrow?
Organisations today face increasingly strict and complex regulations with less time to react, and harsher violation penalties. These new and rigorous demands mean all industries should be focusing on the competence and quality of their existing structures and continually seek new ways to monitor change, ensuring their compliant status within the market. This article will focus primarily on the numerous ways organisations and industries can begin monitoring sources in their environment and successfully anticipate changes in business regulation.
The financial crisis of 2007 exposed major regulatory failures in the finance industry. Since then an increasingly digital and connected global environment has magnified the negligence of companies in the form of NGOs, charities, independent regulatory bodies, lobbyists and consumers. The need to protect the environment, resources, animals, consumers, health, personal and collective data is ever increasing and influencing regulation.
Regulatory Monitoring…How to Really Target Sources and Find Alerts?
The American Contact Dermatitis Society with the help of clinical experts in the field of dermatitis, are continually researching and investigating harmful ingredients in cosmetic and consumer goods that induce and aggravate dermatitis and allergies. Every year for the last 18 years an ‘Allergen of the year award’ is selected by experts in the organisation. It was designed to draw attention to an ingredient or material in need of investigative research by manufacturers, companies and the government because of its skin harming properties, in order to change regulation.
Years of sales and approved clinical trials do not indicate a product and its ingredients contents are safe. Long term side effects and research of certain ingredients can cause a product to be recalled, discontinued or banned creating huge losses. By monitoring existing and new releases of information by experts and consumers, a company can create a radar and actually listen to recurring concerns in a chronological timeline. The earlier you address concerns, the easier it is to implement damage control and find alternative solutions.
Key words found in clinical trials, published expert reviews, health and product forums, social media comments, news reports should all be monitored. The same ingredients causing concern in that particular country and continent should be investigated in other parts of the world to check their status and reputation. Companies in the cosmetics and pharmaceutical industry need to practice constant vigilance and can do so by setting up real time alerts in their monitoring.
Every continent is starkly different in terms of ingredient regulation and this is greatly reflected by artificial colorings. In 2009, after 3 decades of consumer health complaints, the UK Food Standards Agency urged the call for manufacturers to expel 6 artificial colors and lobby for a European wide-ban. University research linked the additives to behavioral problems in ordinary and ADHD diagnosed children as well as inducing eczema and asthma. But the call was rejected after pressure imposed by the food industry and a voluntary removal was suggested. Cadbury and Haribo among many more, voluntarily reformulated hundreds of products, temporarily or permanently removing them from shelves, affecting their reputation and revenue.
This is a good example of why food manufacturers need 360 degree monitoring of their environment. The confectionery companies were not specific in their monitoring, neglected their consumer feedback on social media and the discussions concerning harmful ingredients by reputable sources. In this case, universities and independent bodies are conducting research to impact lobbyists and government legislation and should also be monitored. The FSA can never be certain an ingredient is absent of risk because of scientific limitations, therefore these ingredients are used based on the best evidence available at the time. This is the case for additives and is the reason classifications and regulations are still changing.
Why Anticipation Is Key…the Impact on Companies
The impact from having products taken off the market leaves room for them to be replaced by competitors. For large companies, the impact can amount to multi billion dollar losses. A recall requires the cost of retrieving, fixing and replacing a product from entire regions on a national and international scale. Customers can opt to receive a replacement or refund their product. These costs are absorbed by manufacturers and companies, creating devastating impact.
In 2010 there was a voluntary recall of 42 over-the-counter children’s medicines, from a Johnson & Johnson subsidiary. The medication included liquid versions of Tylenol, Tylenol Plus, Motrin, Zyrtec, and Benadryl. It was determined these products did not meet the required manufacturing specifications and were recalled in at least 12 countries. More than 136 million bottles of liquid Tylenol and Motrin for infants and children were found to be contaminated with particulars of metal. It was UN bodies that called for more research and clinical trials and Unicef and the World Health Organisation that published a list of children’s medicines exposing the dangers. The situation was handled so badly the subsidiary became the subject of a criminal investigation, pleading guilty and fined $20 million, as well as forfeiting $5 million.
Companies often wait till conclusive evidence by government agencies is reported before taking action, but by conducting the anticipatory actions suggested above, many can change their product ingredients before regulation is changed, ahead of their competition and in advance of penalties.
Using Alert System Deliverables
Companies adopting a Digimind solution have been monitoring the position of major political leaders, lobbies, activists, NGOs and more on a global scale. Surveillance has been their key to success through real time detection, efficient reaction and response times.
An international client and government organisation was able to monitor migration policies and regulations worldwide thanks to the sourcing capabilities of their Digimind tool. The department is responsible for implementing its country’s foreign policy and ensuring good relations with foreign states. The tool allowed them to monitor parliaments, international migration organizations (UNHCR….) and local specialized institutions (OFPRA…) using a keyword filter, and important information such as new laws and regulations were validated into newsletters and sent to the minister of the cabinet through an alert system. They used the information to make new recommendations and answer deputy questions. Some of this information even served to build new laws on migration.
A regulatory body for cigarette ingredients has the authority to regulate the marketing and sales of all tobacco products with the aim of protecting consumers, underage children and public health from the dangers and side effects of tobacco. The US FDA for example, may soon reclassify e-cigarettes as an over the counter drug. Thanks to Digimind sourcing capabilities, a regulatory body now monitors the latest studies, news and classifications of ingredients to make an informed decision on the evaluation and revaluation of products. It also helps them to ensure dangerous and counterfeit ingredients do not make it to sale. Each and every time a regulation is changed it can affect the entire product cycle, from manufacturing to sale. An alerts system providing reports to all stakeholders in real time ensures the situation can be handled immediately by everyone involved, no matter their location.
In conclusion, the more an organisation prepares, practices and implements an up-to-date anticipatory stance, the better it will fair in the ever changing landscape of regulation. By regularly conducting research on new and growing sources of monitoring, an organisation can stay ahead of regulation, competition and damaging infringement penalties.