{"id":18066,"date":"2025-07-22T13:19:58","date_gmt":"2025-07-22T11:19:58","guid":{"rendered":"https:\/\/www.clarkemodet.com\/?p=18066"},"modified":"2025-07-22T17:47:46","modified_gmt":"2025-07-22T15:47:46","slug":"is-your-global-strategy-aligned-with-the-potential-impact-of-cmeds-new-reference-basket","status":"publish","type":"post","link":"https:\/\/oldweb2025.clarkemodet.com\/en\/articles\/is-your-global-strategy-aligned-with-the-potential-impact-of-cmeds-new-reference-basket\/","title":{"rendered":"Is your global strategy aligned with the potential impact of CMED\u2019s new reference basket?"},"content":{"rendered":"\n

The draft of Public Consultation No. 1\/2025, issued by Brazil\u2019s Drug Market Regulation Chamber (CMED)<\/strong>, proposes a structural revision of the country\u2019s drug pricing rules. One of the most significant changes is the expansion of the reference country basket<\/strong> used for international price benchmarking.<\/p>\n\n\n\n

Although the proposal is still under public consultation, its level of detail and technical foundation suggest a clear direction: pricing will no longer be defined solely by product characteristics or local conditions \u2014 it will increasingly reflect the company\u2019s global positioning<\/strong>.<\/p>\n\n\n\n

More countries, more attention to global strategy<\/strong><\/p>\n\n\n\n

The draft rule establishes that the ex-factory price (PF)<\/strong> will be based on the prices practiced in at least five of the following countries: Germany, Norway, Japan, Mexico, Australia, Canada, Spain, United States, South Africa, France, Greece, Italy, Portugal, and the United Kingdom \u2014 in addition to the country of origin.<\/p>\n\n\n\n

With a broader basket, the benchmarking process now incorporates a wider range of regulatory environments. Each country applies its own pricing policies, thresholds, and methodologies. This increases variability \u2014 and calls for more strategic coordination.<\/p>\n\n\n\n

Positioning a product in more conservative pricing markets may reduce the ceiling applicable in Brazil. This already existed to some extent, but the logic is now more clearly defined. The key point is not risk, but the opportunity to use public data to make better-informed, globally aligned decisions<\/strong>.<\/p>\n\n\n\n

Instead of navigating in the dark, companies now have a map \u2014 as long as they know where to look and how to read it.<\/p>\n\n\n\n

Generics and the ripple effect<\/strong><\/p>\n\n\n\n

The proposed rule maintains the 65% cap on the reference price for generics. However, if the reference product is already affected by a lower international price, the generic enters the market with a compressed margin from the outset.<\/p>\n\n\n\n

For example, if the PF for a reference product is set at R$100, the generic will be capped at R$65 \u2014 regardless of local production costs or clinical value. A pricing decision made in one country directly shapes the commercial viability in Brazil.<\/p>\n\n\n\n

What can be done now<\/strong><\/p>\n\n\n\n

Even during the consultation phase, the sector can begin preparing for potential impacts. The CMED draft is extensive and technical, covering a wide range of scenarios \u2014 from innovative drugs to changes in market authorization holders.<\/p>\n\n\n\n

Some proactive steps include:<\/p>\n\n\n\n