Competition update – The European Commission continues scrutiny of life sciences companies скачать в хорошем качестве

Competition update – The European Commission continues scrutiny of life sciences companies

Key takeaways from this Pharma forum 2021 session include: -Two key competition issues facing the pharmaceuticals industry are the fallout of the EU Sector Inquiry 2009 (particularly, measures to delay entry of generics) and the recent focus on excessive prices. Other issues include: co-promotion and co-marketing agreements, R&D cooperation, patent pools, the exchange of competitive sensitive information, discussions at trade associations meetings, and vertical price coordination between companies. -Case Study #1: The Lundbeck "pay for delay" judgment saw Lundbeck fined €93.8 million for paying four generics companies not to compete with it by producing generic versions of its citalopram drug. Lundbeck also bought and destroyed stock of generic medicines and offered guaranteed profits in a distribution agreement. On appeal, the General Court confirmed these agreements constituted market sharing, while a 2021 CJEU judgment confirmed that "pay for "delay" agreements are automatic infringements. -Case Study #2: The Aspen commitments decision began with a 2017 European Commission investigation into Aspen's pricing behaviour regarding six off-patent cancer medicines. The Commission was concerned that Aspen was engaging in "price gouging", since it had purchased the medicines in 2012 and increased the price across Europe by several hundred percent. Aspen sought to settle the case and offered commitments regarding its behaviour (including price reductions and caps, and supply guarantees) which were accepted in 2021. -Each jurisdiction has its own merger control regime, thresholds for notification and timetable; within Europe, consider the EU regime first, then that of each individual Member State. There are mandatory and voluntary merger control systems, and authorities can approve (with or without conditions) or prohibit acquisitions. Merger control should be considered early, as there are significant implications on timing and cost if filings are required and there are competition concerns. If you have any issues, it's important that you address these upfront with the regulator and lead the process as much as possible. -A "killer acquisition" is when an incumbent company acquires another company that has a pipeline product that would be in competition with the acquirer's own product, whether on the market or in the pipeline. The theory of harm involves incumbents acquiring their potential rivals thereby preventing future competition. Often the target is small, so the acquisitions don't hit the merger control thresholds and there is no need to notify for clearance. The products are also so new that targets there may not be reliable data available to assess the transaction. -In killer acquisitions, the incumbent usually discontinues the new product, and competition is removed. Competition authorities are becoming increasingly concerned with these acquisitions and the effect on innovation.