An interview with Oscar Rivera, Strategic Business Director at PQE Group
Could you give our readers an overview of your professional background, and how your work at PQE has led you to cannabis?
I have spent almost twenty years working in the pharmaceutical industry. I have worked with pharmaceutical companies, and with some of the most notable drugstores, such as Walgreens in Mexico. Currently, I’m a member of the PQE Global Cannabis Team: in this, I’ve developed several projects in LATAM to support companies in achieving high levels of quality in product development, manufacturing, controls and in their distribution processes.
Across Europe, each country has differing regulations on the permitted uses of cannabis and its derivatives, in addition to directives given by the European Union. For cannabis organizations looking to distribute products across a variety of European countries, what options are available to them?
Firstly, it is key to understand the responsibility of the European Medicines Agency (EMA) that allows a single EU-wide authorization for the marketing of a pharmaceutical drug. Additionally, there is a decentralized procedure, in which companies can apply for simultaneous authorization of a medicine in more than one EU Member State.
There is also a mutual recognition route, in which companies that have a medicine authorized in one EU Member State can apply for said authorization to be recognized by other EU countries. These differing options enable companies to select the route best-suited to their organization and products – ascertaining which option is best suited to your company is always made easier by seeking consulting support!
What happens to an organization if they fall foul of regulatory requirements on product quality? How would you expect this to impact upon their business operations?
Falling foul of regulatory requirements on quality standards is problematic, first and foremost because poor quality products can put the health of consumers at risk. Secondary to that, a compliance breach will most likely lead to a, at least temporary, halt of business operations, loss of sales and additional costs (to remediate the compliance breach). Moreover, being publicly pulled up for poor quality products can do irreparable damage to the brand and can whittle away consumer confidence – a difficult situation for a company to bounce back from (but not impossible).
It is paramount that if an organization finds themselves in this position, they seek out a regulatory specialist who is able to build a bespoke Risk Assessment Framework, develop a Remediation Plan and put in place robust operational oversight procedures to ensure there are no future compliance breaches.
A small handful of countries have dedicated National Cannabis Agencies. What are the benefits and pitfalls of having this kind of structure?
National Cannabis Agencies are incredibly important. Having a group of experts that specialize in everything cannabis, with deep knowledge of the regulatory and remediation tools is the best way to ensure quality standards and regulatory practices that the industry can abide by, in each respective country.
How likely is it that in years to come, there will be fully standardized global rules and regulations around cannabis production and testing? Any why?
It’s important for rules and regulations to be standardized globally to ensure consistent delivery of high-quality cannabis products that customers are able to enjoy and consume safely. This model is similar to the way that the pharmaceutical industry is governed, and in time, the way the cannabis industry will likely move to (especially for medical products).
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To hear more from PQE, check out their session from June’s GCI Virtual Summit.