Belgium, (Brussels Morning Newspaper) Imagine being denied life-saving medical treatment because you live in the wrong country.
It’s a chilling thought, yet it happens to Europeans every day. Patients’ access to the latest medicines varies greatly among EU members, and the health consequences are often grave.
The European Commission is seeking to fix this problem. It is drawing up a proposal for consideration by the European parliament. But the Commission’s own Regulatory Scrutiny Board just reportedly rejected the first draft, because the proposed changes would impede medical innovation.
Sadly, the oversight board is right. The proposal, while well-intentioned, needs an overhaul.
The European Medicines Agency is one of the most stringent drug regulatory bodies in the world. One might assume that, once the EMA approves a drug, it quickly becomes available across all EU 27 member states.
But this isn’t the case. For instance, Germans have access to 88% of all EMA-approved medicines, according to a 2021 report by the analytics firm IQVIA. In my country, the Czech Republic, patients must make do with 57% of those drugs. In Latvia, just 15% are available.
When the European Commission announced its sweeping Pharmaceutical Strategy for Europe in 2020, rectifying these inequities was a chief goal. This year’s EU legislative update is supposed to be the latest step in the strategy.
Equalizing access is important. But the Commission’s current approach goes about it the wrong way — by cutting back on intellectual property protection for drug developers.
Under current EU rules, certain medications enjoy a 10-year period of “market exclusivity.” During that time, rival companies can’t launch a competing generic drug.
The Commission’s proposal would cut that period back to eight years, but with a catch: Drug makers would be able to regain those two lost years of exclusivity by making their new wares available in all 27 member-states within two years of EMA approval. What exactly “making a product available” means is somewhat ambiguous, given the complicated pricing rules in national healthcare systems within the union.
The thrust of the proposed change, however, is clear. It rolls back current intellectual property protections. Some might describe this as an “incentive.” Another and more accurate word for the proposal is blackmail.
In order to keep their current level of intellectual property protection, drug makers will have to comply with the national rules on availability of all 27 member states. If manufacturers are unable or unwilling, they will lose two years of market exclusivity throughout the entire union.
The proposed chance is projected to cost biotech companies hundreds of millions of euros each year. Drug makers will have to recast all their models to reflect this reduced revenue, inevitably leaving fewer funds available for research and development. Promising avenues of research based on revenue projections from 10 years of market exclusivity may no longer pass muster with only eight. The result will be a less innovative pharmaceutical sector throughout the union.
Under the circumstances, it’s no wonder that the Regulatory Scrutiny Board rejected the proposed change. The legislative proposal offers a once-a-generation opportunity for reform, and it’s important the Commission and the European Parliament get it right.
One huge step forward would be to simplify the approval process at the European Medicines Agency, so that new medicines can clear regulatory hurdles more quickly without sacrificing scientific rigor. Such a policy would support rather than undermine innovation.
Another area ripe for legislative action involves a necessary correction for market failure. Right now, strains of antibiotic-resistant “superbugs” are evolving to resist our current arsenal of treatments. Antimicrobial resistance could take as many as 10 million lives per year by 2050, according to the World Health Organization.
Currently, there are few market incentives to develop new antimicrobial drugs, which by their nature have to be carefully stewarded and used sparingly. The revised legislation could provide new incentives for innovation by, for instance, offering sustainable contracts to companies that successfully launch a new antibiotic.
The Commission’s push for more equal access to medications is a vital one. But it will truly serve European public health needs only if it encourages, rather than punishes, innovation.
