PCP23 - DOES THE EUROPEAN UNION (EU) NEED EUROPEAN HTA OR EUROPEAN PROCUREMENT?

Abstract

Following establishment of the voluntary EU wide network on HTA, the European Commission recently adopted a legislative proposal for a joint EU HTA to be further adopted by the European Parliament and the Council by 2019. By strengthening EU cooperation on HTA, Member States (MS) should benefit from shared experience, as well as best practice to avoid work duplication and to maximize healthcare efficiency gains across EU. In parallel, several EU initiatives on drug procurement are implemented. EU HTA is expected to introduce greater transparency, reliability and consistency to assess clinical added value of new technologies across EU. Fast progress in advanced technologies suggests that a growing number of new interventions with dramatic additional benefit should continue to reach the market at increasingly high price. A single EU HTA agency deciding on drug added value, and implicitly, on its price, may increasingly reduce the ability of small size MS with lower GDP to negotiate prices of such breakthrough therapies, increasing gap in patient access across EU. Key question would be the equitable access across EU because low income countries already cannot afford several new technologies and do not receive appropriate discounts due to external reference pricing. EU drug procurement for a market of 510 million inhabitants would increase dramatically its negotiation power. This procurement should also be complemented by differential pricing to adjust on purchasing power parity. A step wise approach should be recommended. Obvious resistance may emerge due to the health care subsidiarity in Europe, but also mistrust of citizen toward European elite to freely manage national drug access. If EU HTA is needed to set common grounds for value assessment of new technologies, step-wise joint procurement with differential pricing may be the most appropriate tool to contain the ever growing innovative drug cost.