EU Health and Food Safety’s Post

It's Wednesday! Which means it's time for part III of our #EUPharmaReform series. 🤓   Today we are focusing on access to medicines across the EU 💊 👇   Timely and equal access to medicines for all patients across the EU is a core principle of the European #HealthUnion. The proposed #EUPharmaReform will help deliver that.   💡 Why we need to act?   Today, where you live determines whether you get access to the latest innovative medicines, or not. While most innovative medicines receive a centralised EU marketing authorisation, many of them are only marketed in a few Member States.   As a result, smaller or low GDP Member States often experience limited or delayed access to innovative medicines. Out of the 168 medicines authorised by the Commission between the years 2018-2021, access to those medicines ranged from up to 147 in bigger Member States to as low as 10 in the smaller ones.   💡 What we propose:   The proposed pharmaceutical reform will reward companies that market their medicines in all Member States. A new, modulated incentive system will reward companies for making their medicine available in all 27 Member States with an extra 2️⃣ years of protection from generic/biosimilar competition.   💡 How it will work?   💊 Once a company receives a central EU marketing authorisation, it engages with each Member State to agree on supply according to the country’s needs and how the medicine can be marketed.   💊 Some Member States may waive the condition of supply of the product at that moment. In such cases, a company would be given a waiver or tacit consent, so that it can still be granted an extra 2 years of protection.   💊 Negotiations typically result in actual supply of the medicine according to the needs established by each Member State.   💊 The incentive is only withheld if the interested Member State and company fail to reach a mutually acceptable supply agreement. Other incentives might still apply.   💊 SMEs, not-for-profit entities or those with limited experience often require more resources and time to access national markets and negotiate with administrations. Therefore, small companies receive an additional year for marketing in Member States and an extra year for administrative arrangements. Check out the visual explanation 👉 https://europa.eu/!HPDNqH   The result? ✅ 67 million more patients in the EU will obtain access to innovative therapies.   Even if the innovative product is not marketed in all Member States, patients still stand to win. The new incentives system means that patients will have faster access to affordable generic or biosimilar medicines if a product is not marketed in all EU countries. And companies that deliver on important public health objectives will be rewarded with more regulatory protection than today.   Check out more information about the access to medicines here: https://europa.eu/!fwTRFW #HealthUnion #EUDelivers