- Executives from Eli Lilly and Novo Nordisk, in addition to others, made comments at BIO in favor of a policy which would make regulatory harmonization between the FDA and the EMA a binding regulation of TIPP, a transatlantic trade agreement that is being heavily negotiated, according to in-Pharmatechnologist.
- Many pharma companies are in favor of this TIPP policy, but many consumer and civil society groups are not.
- Those who are in favor of the policy say that since companies on both sides of the Atlantic will have the same rules for conducting trials and performing inspections, less duplication will be necessary—which will lead to cost-savings.
At face value, a TIPP clause that seeks to align regulations and trial design and saves money in the process should be good for everyone, companies and patients alike. But many groups that oppose the policy have a different perspective. According to groups such as NGO Health Actional International (HAI), the type of harmonization outlined in the TIPP policy could compromise patient safety. They also argue that this policy could give biopharmaceutical corporations an outsized level of influence with goverments, because once their interests are completely aligned on the regulatory side, they will have more lobbying power.
An important point: Given the fact that most large biopharma companies have a global presence, having a completely decentralized regulatory system is not the most efficient way to bring drugs to market for large groups of people beyond the borders of one country.
There is already an agreement in place dating back to 2003 between the FDA and the EMA that involves cooperating on certain regulations, as well as sharing confidential information and collaborating on various scientific issues. Nonetheless, the TIPP agreement would address many of the longstanding gaps where there is a lack of cooperation between the FDA and the EMA.