Reports of supply shortages of breast cancer medicine (Tamoxifen) in Germany raise legitimate concerns for patients and highlight the difficulties faced by off-patent medicines manufacturers operating in markets driven by cost-containment policies. For the generics industry, the priority is to avoid bottlenecks in supply as far as possible and make sure patients can continue to access the medicines they need. We must then urgently address the universally strict cost-containment measures, which force generic medicines prices into a dangerous downwards spiral, often below the cost of goods, which are currently rising driven by steep levels of inflation.
When cases of limited supply of essential, off-patent medicines occur, the root of the issue can usually be identified by asking three key questions:
- How many companies produce and supply this medicine? Where there are few suppliers on the market, if one has an issue, the others may struggle to cover the supply gap, especially where the production is complex.
- How has the pricing policy shaped the market? When health systems focus on pricing only in policies, many other important factors, like supply security, are ignored. In Germany, prices have been capped and off-patent medicines further tendered, which increases the risk of shortages. A box of 100 Tamoxifen costs 8.80eur in Germany. This price barely covers production costs and disincentivises investments in a resilient supply chain.
- Does the EU regulatory system allow companies to find quick solutions? We support a stringently regulated EU market for medicines safety, quality, and efficacy. However, regulatory processes and procedures must be sufficiently streamlined and flexible to facilitate patient access to medicines. In shortage situations, there should be accelerated procedures to introduce necessary changes.
This is indicative of a growing trend, also highlighted by the Technopolis Study on Medicine Shortages, of generic market policy failures caused by disproportionate and short-sighted cost-containment measures combined with rapid increases in inflation.
We call on the EU and national authorities to put patients first and to start correcting the functioning of unsustainable procurement and tendering policies in the EU. This means to:
- Ensure market predictability where tenders are only used when needed, planned, clear, transparent, and reward secure, multi-source supplies of essential medicines.
- Avoid short-term cost containment measures like mandated price reductions, internal and external reference pricing, tendering and payback mechanisms to already low-priced generic medicines.
- Prevent disproportionate sanctions that can increase the risk of medicine shortages.
- Improve regulatory efficiency to reduce the administrative and cost burden of keeping medicines in the market and to enable rapid changes to supply chains and cross-country product allocation.
- Engage with medicines manufacturers to address the root causes of medicines shortages and find concrete solutions.
The priority of Medicines for Europe members is to stabilise patient access to essential medicines. We must be met with realistic proposals and policies from our partners to address this continued situation and find real solutions for essential medicines and the patients who rely on them.
For more information on the situation in Germany, see https://www.progenerika.de/presse/tamoxifen/ and Q&A on https://www.progenerika.de/updates/lieferengpaesse-beim-brustkrebs-wirkstoff-tamoxifen/
Medicines for Europe position on medicines shortages https://www.medicinesforeurope.com/docs/20170927_Positionpaper_medicines%20shortages.pdf