Biopharma: how Affiliate Quality can contribute to the overall success

Philipp Hespe
Director, PwC Switzerland

Making sure that the highest quality medicines consistently reach healthcare professionals, hospitals and patients is, of course, a key concern for biopharmaceutical companies. That vital role is played by Affiliate Quality (AQ) organisations that take responsibility for the oversight and control of distribution, safeguarding a reliable supply of high-quality products and ensuring product surveillance.

But health markets and the biopharmaceutical landscape are becoming ever more complex and dynamic. That’s as a result of a number of drivers including rapid advances in digital technology, innovative new medicines, regulatory developments and more. In this fast-changing context, it’s essential that AQ organisations can keep pace and remain fit for purpose. To find out how well they are achieving that goal – and the barriers they face to do so – PwC carried out a benchmarking survey of ten of the world’s largest 20 biopharmaceutical companies.

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A source of competitive advantage

Our survey revealed that the majority (67%) of companies see their AQ organisations as a source of competitive advantage. By ensuring a reliable supply of products, dealing with patients’ enquiries and complaints, and liaising with regulatory authorities, AQ organisations help to secure companies’ licence to operate and protect their reputation. In addition, some companies harness AQ’s well-developed analytical, methodological and management capabilities to drive improvement across affiliates. This, in turn, has the additional benefit of making AQ resources’ jobs more attractive. 

The need to evolve

However, we also discovered that faced with a growing workload, many companies face the challenge of operating with constrained or limited AQ resources.  While overall there is a clear consensus among companies that AQ organisations add value, it’s equally the case that AQ must continue to adapt in order to ensure it remains fit for purpose. They may, for example, need to acquire new capabilities to support digital medicines and telemedicine. Consequently, all companies we surveyed recognise the importance of evolving their AQ organisations in light of the fast-changing context in which they need to operate. And to achieve that many of the leaders are actively seeking ways to make AQ roles more attractive.

Leading the quality agenda

Our survey highlights that some companies are more keenly aware of the competitive advantage that AQ can confer and are consequently investing more time and effort to secure it.

They are doing this through several initiatives. Establishing AQ as a clear full-time career path, with possibilities for development and advancement, is one clear trend. In addition, leaders are helping their AQ resources to play a more strategic role by enabling them to partner more closely with the business.  We’re also seeing AQ organisations and resources becoming more centrally directed, with AQ “hubs” helping to drive quality of service, standardisation, and operating efficiency. Creating the right enabling technologies and platforms is also critical. Our research identifies that there is considerable scope across companies to increase the extent to which AQ is supported by digitisation and automation. 

Follow the leaders

Overall, it’s clear that AQ plays a vital role. But in the context of a rapidly developing biopharma industry and market place, that role must evolve with the times to be future-ready. Some leaders are already showing the way forward. Others would be wise to emulate their example. 

The New Equation

Get more insights

Find out the best practices that are enabling Affiliate Quality to become a true partner to the business and the importance of making career development in Affiliate Quality just as attractive as it is for their peers within biopharma companies:

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Contact us

Bodo Baumeister

Bodo Baumeister

Partner Advisory | Basel, PwC Switzerland

Tel: +41 58 792 1505

Philipp Hespe

Philipp Hespe

Partner, Swiss Quality and R&D Lead, PwC Switzerland

Tel: +41 79 592 79 55