Outsourcing is an inevitable necessity in the Pharmaceutical industry. It happens at almost every stage of the development of a drug. And spending on outsourcing continues to grow. According to Transparency Market Research, the global regulatory affairs outsourcing market had a valuation of US$1.9bn in 2014. The market is expected to expand at a substantial 11.5% CAGR from 2015 to 2023 and rise to a valuation of US$5.7bn by 2023.
The ever-increasing complexity of requirements placed upon Pharmaceutical companies creates new and unprecedented challenges with which companies must work with. These are a blend of internal and external factors such as:
So, the challenge that companies face is how to maintain their standards, work more efficiently and maintain or increase market share? The answer to this is to focus on core competencies.
In terms of regulatory maintenance, it is typical that pharmaceutical companies want to drive commercial success by focusing on developing and differentiating their pipeline with pricing, reimbursement and access strategies typically. So, in line with this, what do companies look to outsource first?
Which Regulatory activities to Outsource?
Well, our experience has been that usually, and naturally, the activities that our clients think about outsourcing first are usually related to tactical operations such as document management. The reason being that these are typically viewed as essentially “low risk” and therefore easier to justify outsourcing. However, they are still incredibly important.
“Routine maintenance” lifecycle activities (e.g. label or manufacturing changes and renewals) are considered low risk. However, they are critical to a company’s bottom line and success (or otherwise).
Whilst R&D are the lifeblood of a pharmaceutical or biotech company, regulatory compliance, while perhaps less strategic, is vital to earnings and growth. Submitting regulatory paperwork that is accurate and meets submission timelines is critical. Moreover, as the number of products to maintain increases (Life Cycle Management) and the more markets and the company enters, the more it makes sense to consider outsourcing.
Which Pharmacovigilance activities to Outsource?
Pharmacovigilance is an issue that has grown in recent years to become a core focus of companies who want to maintain that focus on core competencies. For “Big Pharma” (whether that be the originators or the Generics), Pharmacovigilance is typically an insourced activity. But for those with smaller resource or less global reach, outsourcing Pharmacovigilance can be a necessity, rather than a desirable.
Dependent upon the resource, strategy or approach to risk, it can be common that elements of Pharmacovigilance such as Case Processing can be outsourced rather than the whole system. But for others, having a service provider with an experienced team of QPs and backups is the safer approach. In this scenario, it is expected that that provider will have a system comprising of a recognized validated database and all that comes with this. It is also imperative that such a provider has passed a Health Agency inspection. Moreover, considering Brexit, it is now the safe option to consider a provider with its system and QPPVs outside of the UK. Many companies considering risk minimization would consider having their EUQPPV in a soon to be non-EU country not wise.
“Local” Outsourcing – Regulatory and Pharmacovigilance
Growth and profit is more than ever contingent upon on international market share and, in the biopharmaceutical industry. This leads to a second outsourcing issues – local support. As regulations changes, are hard to follow or simply require people “on the ground”, where a broader level of local understanding exists, now, more than ever before.
Markets such as LATAM, China, India, GCC/MENA, ASIAPAC and CIS are highly coveted and come with their own set of rules. In the European Union, where Arriello has 2 sites, we see that even though there is one EU Agency (EMA), there are still 28 member countries (until after Brexit). Depending on the registration approach, it is possible that each country can have their own interpretation of “common” regulations. This is even more reason why local expertise is necessary.
It can take well over a year to launch a product in a new market and that time can be all it takes for a company to lose its advantage. The need for local, regional and national regulatory expertise is intense and the supply of available experts is an issue. Therefore, it is key that if you are considering outsourcing Regulatory Affairs and Pharmacovigilance functions, that the selection process of a vendor considers critical criteria:
The cost of outsourcing, whilst important, is not usually the number 1 factor in decision-making. What is usually more mission-critical is having access to knowledge and flexible resources.
Secondly, to assess effectiveness, the outsourcing partner needs to have relevant metrics to measure how successful the partnership is. Timeliness and quality are fundamental in regulatory compliance and key to a solid partnership in outsourcing. Finding a partner with regulatory or pharmacovigilance experience, international maturity and technological expertise will give you a much-needed advantage in today’s demanding marketplace.
And last, but not least, excellence in project management, and transparency in communication are the most important underlining factors in forming a successful partnership.
Building the internal infrastructure to maintain internal and external control has been the core focus of Arriello over many years. It includes having and maintaining:
We are happy to consult you on how you can enter new markets, manage your life cycle more efficiently or simply look at how outsourcing can allow you to focus on your core competencies.