Transfer of Marketing Authorisation: Mergers, mega-deals and the expanding opportunities in pharmaceutical industry

By Alma Salibasic

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Marketing Regulation Biopharmaceutical

Q&A with Alma Salibasic, regulatory affairs manager at ICON.

BPR: What is a Marketing Authorisation Transfer and what does it have to do with mergers and acquisitions in the biopharma industry?

A Marketing Authorisation Transfer (MAT) is a regulatory procedure for transferring ownership of a medicinal product from one company to another. The transfer vests the new Marketing Authorisation Holder (MAH) the legal right to distribute, sell and commercialise the authorised medicinal products.

This kind of a transfer may happen as a result of therapeutic portfolio management activities and/or mergers and acquisitions (M&A), where companies seek ways to grow, maximise profits and operate more efficiently. Depending upon the country/region in question, the process of transferring a marketing authorisation can take from a few weeks to up to a year and requires approval from the Competent Authority in that specified country.

BPR: What are the new regulatory and legal responsibilities that an acquiring company will have over a medical product?

The acquiring company will be responsible for ensuring product quality, efficacy and safety. They must consider proper implementation of pharmacovigilance and risk management practices, in place at transfer approval, as well as compliant promotional activities and continuous supplies of the product, so batch release and supply chain/financial flow considerations should comprise the core of any MAT planning activities.

In terms of legal responsibility, the new MAH and any parties working for them should comply with all relevant requirements set out in regional/national legislations and guidelines. It should also be noted that the level of MAH responsibility remains the same regardless of the structure and number of companies involved in commercialising the product – from any separate unrelated companies working for the overall MAH holder to a number of separate legal entities working together but that ultimately belong to the same parent group.

BPR: Why is it particularly difficult for a mid-sized or small emerging company to take over an existing approved medicinal product? How can an experienced strategic partner like ICON help?

An MAT is more than just a post-approval administrative procedure. The types of transferred medicinal products, the number of products, and relevant laws and regulations in each market, are different and may determine the complexity of the MAT. The complexities are compounded when a mid-sized or small company acquires a commercialised product and does not yet have established capabilities, systems and processes in place to transfer the MAT, comply with the obligations of the MAH, and maintain compliance of the product moving forward.

This is where a strategic partner like ICON can help. An experienced CRO partner can provide support and domain expertise in a flexible model to support such companies in timely, efficient and compliant transfers, as well as providing other necessary services to maintain compliance in such fields as pharmacovigilance and life-cycle regulatory maintenance.

An experienced strategic partner will assist the acquiring company with strategic planning, navigate the regulatory complexities of MATs by prioritising product supply to markets and by supporting regulatory activities including but not limited to preparation of regulatory submission packages, managing transfer-related regulatory risks and aligning transfers with ongoing critical regulatory submissions. A strategic partner can also manage cross-functional regulatory activities to successfully transfer marketed products.

BPR: Why is early regulatory and cross-function readiness important when planning an MAT?

Any MAT entails a complex process, from a supply, regulatory and compliance perspective. When M&As occur, it is often necessary to rapidly make regulatory impactful decisions and execute them immediately. Any delay has the potential to disrupt business continuity and result in supply shortages, which impacts patient care as well as financial and reputational implications to the business.

Consequently, MATs require increased cross-functional activities to properly address the responsibilities that come with the product ownership transfer within the new environment. This involves detailed planning and execution. MATs processes vary across each market/region, the nuances of requirements in different jurisdictions, in addition to companies’ organisational structures are two reasons why regulatory and cross-functional readiness are so important when planning a MAT.

The early involvement of an efficient Global Regulatory Affairs team with experience of diverse markets as well as access to regulatory guidance for different products will support a cost-effective, timely and comprehensive MAT.

BPR: What are your predictions for the next year for the M&A landscape in the pharma and CRO industries?

While 2022 may not have reached the heady heights of 2021, the general consensus amongst most analysts and market observers is that there is a positive outlook in 2023 for life sciences M&A, with pharmaceutical companies seeking innovation and diversification in their portfolios.

The year has started strongly – in January, AstraZeneca, Ipsen and Chiesi contributed around $4 billion in biopharma deals. We would certainly see the outlook being favourable also - with increasing reliance on decentralised trials and digital healthcare, companies will need to focus on digital transformation, which is likely to drive substantial investments in capability in this regard.

Overall, we think that companies will continue to look to drive growth and innovation with strategic M&A activity, notwithstanding the challenging macroeconomic conditions worldwide.

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