< PreviousREGULATION 20 Pharma Business International www.pbiforum.net © Shutterstock /pcruciatti 20-23.qxp_Layout 1 13/08/2021 11:19 Page 1Pharma Business International 21 www.pbiforum.net REGULATION Regulatory hurdles have always been a problem in the pharma market, be it their stringent requirements or the sheer amount of time and cost it takes to get anything through them. In the past, this has always been at least somewhat understandable given the potential risks of drugs and the lack of any rush felt by the market. Now, things have changed. COVID-19 has not only shown the world how unprepared we were for a global pandemic, but it has also been a kick in the rear to many Governments and regulatory bodies. During the height of COVID-19, pharma companies were able to work collaboratively to push vaccines through expediated regulatory processes. These processes were no less stringent than before – in fact, they were in some cases even more so – but they were much faster. Much more efficient. The question is whether these parameters will be kept after COVID-19 is gone, or whether the process will revert back to its sluggish former self. With fresh strains of the virus coming out, there will be no reversal yet. In fact, demand for clinical trials is increasing as companies try to combat the latest variants of coronavirus. One response to this has been to decentralise the process of gathering patient information and easier access to regulators in order to plan trials or any changes to them. Similarly, trials have become more decentralised, with more rapid and diverse patient recruitment and faster start up times spurring greater efficiency, as well as a faster return on investment. The fear is, and has been among the general populace, that faster trials will be less safe. This is an argument used by Changing hurdles With all the changes caused by COVID-19, how has the regulatory market fared? Will there be any changes in the future? 22 Á 20-23.qxp_Layout 1 13/08/2021 11:19 Page 2REGULATION 22 Pharma Business International www.pbiforum.net many anti-vaxxers for justification why the COVID-19 vaccines are unsafe. While many of their arguments can be dismissed, it goes without saying that decentralisation, while good for efficiency, will inevitably be abused if it stays as it is. Less scrupulous pharma companies will take advantage of it, and with enough trials going through, it is bound to happen sooner or later that standards slip. What is needed therefore is an overhaul of much of the system, with an aim to continuing the decentralised and more streamlined trial process, but with changing regulatory bodies prepared to adapt to the new demands. This would be a natural evolution of a process that has by now become mired in red-tape and bureaucracy. There is plenty of demand and profit to be made in this as well. Predictions for the coming years have the regulatory affairs outsourcing market coming in at $14.3 billion by 2026, a CAGR of twelve per cent. With so much money in the market, and with pressure from people to be ready to adapt should further waves 20-23.qxp_Layout 1 13/08/2021 11:19 Page 3Pharma Business International 23 www.pbiforum.net REGULATION © Shutterstock /Den Rise of COVID or any other future pandemic strike, it would be the height of negligence for the regulation process to go back to what it was before. Regulatory bodies have already released a host of emergency measures which can be repeated for future emergencies, but this is also a rare opportunity to learn from a more expedited process, to see what can be taken from it and applied wholesale to speed up the global pharmaceutical market. Already, there are suggestions that the FDA will be using increasing amounts of remote inspections in the future, which is one area where regulators have seen efficiency improvements that can be extrapolated into the wider market. Allowing remote inspections would cut waiting times drastically and allow regulatory staff to inspect numerous trials and facilities in the time it would previously take to do one. If even this small improvement is taken and implemented, it would mean drastic improvements for pharma companies and a huge shakeup for the industry. 20-23.qxp_Layout 1 13/08/2021 11:19 Page 4LABELLING 24 Pharma Business International www.pbiforum.net Counteracting counterfeits 24-27.qxp_Layout 1 13/08/2021 11:20 Page 1Pharma Business International 25 www.pbiforum.net LABELLING A black market has grown around the production, transportation and sale of counterfeit medicines. With the advent of home broadband and later the proliferation of smart phones, it’s now easier than ever to purchase phony drugs. Consumers can be driven to counterfeits for a number of reasons, with affordability chief among them. However, despite often being cheaper than their counterparts, counterfeit medicines pose a safety nightmare. As they are not beholden to any regulatory body, these products could contain widely different amounts of active ingredients, or unexpected ingredients, putting patients in danger of overdosing. In the ongoing battle against counterfeits, pharmaceutical companies have had to take their labelling back to the drawing board. Demand for safer packaging is on the rise, with the latest forecasts predicting a 12.1 per cent spike between 2016 and 2026. More than thirty per cent of total pharmaceutical products in developing markets are counterfeited and Advances in labelling are helping to stem the rising tide of counterfeit medicines, securing the supply chain and keeping patients safe. 26 Á © Shutterstock /Fresnel © Shutterstock /Dmitry Kalinovsky 24-27.qxp_Layout 1 13/08/2021 11:20 Page 2LABELLING 26 Pharma Business International www.pbiforum.net 24-27.qxp_Layout 1 13/08/2021 11:20 Page 3Pharma Business International 27 www.pbiforum.net LABELLING © Shutterstock /Lubo Ivanko approximately fifteen per cent drugs sold across several sales channel in developed markets are fake. The rampant counterfeiting of drugs has pushed pharma producers to opt for secure solutions. Anti-counterfeiting labelling and packaging is one of the measures that pharma majors are relying on. However, with advancements in technology, manufacturers are also integrating new and innovative options with conventional solutions such as integrating authentication overt features with covert elements, forensics, and track & trace elements. These measures have translated into fruitful results for pharmaceutical companies and tier II pharma companies also prefer similar approaches. These effective measures considered by pharma companies resulted in the sudden increase in demand for anti-counterfeit pharmaceutical packaging across the globe. Innovation in the packaging segment is heralding some robust results. Some of the most common examples of anti- counterfeit measures are advanced holograms, as well as watermarks and barcodes on labelling. As well as presenting a challenge to counterfeiters, these measures also prove costly to recreate, often cutting into whatever profits these manufactures are making on the black market. Track and trace technology is common across a variety of industries, from food to pharmaceuticals. It helps manufacturers follow a shipment from end-to-end, ensuring that what leaves the production line is exactly what arrives in a pharmacy, hospital or supplier. In the event that counterfeit products flood the market, a company can reassure consumers that their own products are safe and secure. But counterfeiters are cunning, and will explore new ways of recreating existing methods, no matter how robust. To that end, the World Health Organisation (WHO) and the US Food and Drug Administration actively encourage the pharmaceutical industry to integrate advanced anti- counterfeiting packaging technology, and to explore new possibilities. In turn, it creates ever more robust solutions, and creates value for makers and suppliers of anti-counterfeit packaging technology. As consumers turn to cheaper alternatives, the risk of taking unregulated medicines that can lead to severe side effects and even death rises. To tackle the issue, manufacturers and regulators are incorporating increasingly innovative anti- counterfeit measures as standard for packages. As the market is forecast for impressive growth over the coming years, it shows the severity of the issue, but also how the solution is going from strength to strength. 24-27.qxp_Layout 1 13/08/2021 11:20 Page 4DISTRIBUTION 28 Pharma Business International www.pbiforum.net Interconnected Interconnected Perhaps more than any other technology, blockchain is taking pharmaceutical and medical distribution into the future. A s digitisation and smart technology solutions will disrupt and transform the development of new drug products, so too will it impact distribution. The pharmaceutical supply chain is far from the only sector which is beginning to witness the benefits of digitising distribution, from utilising smart track and trace software to utilising blockchain technology. In its simplest terms, blockchain allows data to be stored as part of an immutable ledger assuring that it cannot be altered or tampered with. This makes it especially valuable for distribution, where products can be followed in forensic detail through the supply chain. This can help to create a safer, more transparent and trusted supply chain and offer a means of fighting the rising scourge of counterfeit medicines. Blockchain is becoming increasingly important to companies and organisations with a survey from not-for- profit The Pistoia Alliance finding that more than half of professionals in the pharmaceutical and life sciences sectors already either using or experimenting with blockchain. Compare this with the twenty-two per cent when asked in 2017 and the impact blockchain is having on the industry quickly becomes apparent. While this headline figure is cause for exploration and speculation, forty per cent of those surveyed said they are not currently looking at implementing or have no plans to implement blockchain. Although this technology has been around for some time now – growing out of the cryptocurrency sector – its wider applications are still evolving with businesses and organisations taking a cautiously optimistic approach. There are, however, barriers and challenges that first need to be considered and ratified before they can be overcome. For example, fifty- five per cent of those surveyed claimed that access to skilled blockchain personnel is one of the biggest barriers, while sixteen per cent said that blockchain is simply too difficult to understand. Access to skilled personal is, of course, the bigger challenge to overcome. Blockchain professions will undoubtedly be concentrated in major urban areas, which doesn’t help pharmaceutical and life sciences companies based outside of towns and cities. Until there’s a larger talent pool to draw from, adoption will be slow, especially amongst smaller firms. To that end, The Pistoia Alliance is calling for collaboration between the life science and pharmaceutical industries on the development and implementation of blockchain. Steve Arlington, President of The Pistoia Alliance, says: “We hope the security benefits of the technology help to lessen reticence over sharing and transferring data or information and will facilitate further cross-industry 30 Á 28-31.qxp_Layout 1 13/08/2021 11:21 Page 1Pharma Business International 29 www.pbiforum.net DISTRIBUTION © Shutterstock /Sashkin 28-31.qxp_Layout 1 13/08/2021 11:21 Page 2Next >