India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Amsterdam triumphs: Is the Netherlands a Trojan horse for pricing and drug approval reform in Europe?
Italy's failure to win the EMA relocation vote has been likened to losing on penalties in the World Cup. For the Netherlands, luring the EMA to Amsterdam marks a stunning diplomatic coup that is certain to deliver a sizeable boost to the life sciences sector. The decision may also have interesting developments in store for the future of European drug regulation. One aspect of Amsterdam's bid that was under-appreciated in the run-up to the vote is the Netherlands' avid pursuit of reforms to European medicines approval. These policies will be a worry to the pharmaceutical sector.
The Netherlands' former Minister for Health Edith Schippers was unequivocal in pitching the country's bid for European drug regulator by stating that the "EMA is part of a system in dire need of rethinking and modernisation". Since the Dutch EU presidency in 2016, the Netherlands has proposed a series of reform measures intended to increase access to essential medicines. The country has also tried to focus policy attention on pharmaceutical pricing issues, including being at the forefront of joint medicine evaluation and negotiation initiatives, such as BeNeLuxA. More recently, it proposed a European medicines pact to ensure more equal access to new medicines for all EU citizens regardless of the country they reside in. The proposals state that when a new innovative medicine receives final market-authorisation clearance from the European Commission, the manufacturer should be required to offer the drug in all EU member states within a certain time frame. In other words, the Netherlands is looking to ensure that pharmaceutical companies are obliged to guarantee that patients in all EU member states can benefit from a new drug to secure market approval. This concept was implicitly connected to the Netherlands' bid to host the drug regulator. Indeed, the policy may have tailored to these ends knowing it would find support among Central and Eastern European countries that often experience market access delays lasting months.
The concern for the pharmaceutical sector is that the Netherlands' reform-minded policy nature may be given added momentum by virtue of having the EMA on its doorstep. The government may have gained substantial new political and regulatory influence to pursue ambitious reforms to the EU pharmaceutical market. Greater visibility and clout among smaller and medium sized European countries could mean that the pharmaceutical sector faces the increased risk of new or expanded price negotiation strategies to contain the cost of innovative medicines. Certainly, the country will in future wield an outsized influence, totally disproportionate to the relatively small size of its market.
There is a counter-argument, although it is probably wishful thinking, suggesting that Dutch policymakers might become slightly more protective of the innovative pharmaceutical sector. As the Netherlands now has more at stake, the argument goes, it might be less willing to pursue potentially industry hostile policies on drug approval and pricing systems. These policies could undoubtedly do damage to parts of the innovative sector that operates in Europe. However, the early indications are that, even with its new prize, the Netherlands won't hold back on controversial policy fronts. On the other hand, the selection of the Netherlands is clearly a good choice as a safe pair of hands for the European drug regulator. Culturally Amsterdam is very similar to London and should be a neat fit for staff and their families. The outlook for the EMA business continuity plan is reasonably positive, at least more so than for the majority of other candidates. Within a two to three year period following the transition of the EMA to Amsterdam, the agency should have fully recovered its capacity for drug regulation and pharmacovigilance activities. In the interim, the choice of Amsterdam as the EMA's custodian should mean the rate of drug approvals is mostly sustained.
Eóin Ryan is a Senior Life Sciences Analyst at IHS Markit
Posted 28 November 2017
- India issues new clinical trial rules to expedite new drug approvals
- Medicare X
- Pharmacare for all in Canada: Unlikely proposal to imminent threat
- Accuracy check: Norwegian health expenditure data
- Budget impact of passing a share of negotiated manufacturer rebates to patients at POS
- United States experience dramatic shift in public share of healthcare spending
- Population health outcomes of American patients under different drug access conditions
- Improving Access to Medication-Assisted Treatment for Opioid Use Disorder among the Commercially-insured US Population
Democrats explore creative ways to expand health insurance access with Medicare X https://t.co/kAsNBvtiuz
The creation of the Canadian Drug Agency and Pharmacare could mean big changes for drug prices https://t.co/8uMsHLXiAE