EU’s Pharma Reform: Take a dig into Inside story with Pharmaways

Source: Politico.eu

Can the European Union bring eye-wateringly expensive medicines to the poorest parts of Europe, find cures for untreatable diseases, and solve the problem of antimicrobial resistance, all with a stroke of its pen? 

That’s the ambition of the upcoming revision of the EU’s general pharmaceutical legislation — the biggest reform of the bloc’s rules for medicines in close to two decades — and the European Commission’s proposal is set to land in March.

The reasoning behind the incoming legislation is simple: Left to its own devices, the market for drugs isn’t working. Many patients have to go without medicines, either because they aren’t sold where they live, or because they simply don’t exist.

The Commission thinks that it can change this with a careful mix of carrots and sticks. The hope is that pharmaceutical companies will fall in line in order to keep their access to the EU’s aging population — and their fat wallets.

There are detractors on either side of the issue. Industry supporters say the changes will make Europe less competitive by watering down intellectual property protections as the U.S. and China pull ahead. On the other side, health NGOs see the proposals as freebies to pharma that will cost public health systems money they can’t afford. 

Surveying the scene from above the fray, POLITICO takes you through the main planks of the proposal.

Leveling the playing field

If you’re a patient in Romania, Poland or Bulgaria and you need a recently approved medicine, you have to wait more than 800 days on average before it becomes publicly available. In Germany that figure is 133 days. That’s according to data from the European Federation of Pharmaceutical Industries and Associations.

The discrepancy is a sore point for Health Commissioner Stella Kyriakides, who has staked her legacy on building a “European Health Union.” So far, that’s meant improving the bloc’s crisis response capacity. But the reality is that Europe’s health systems remain fragmented and unequal.

A proposal in a draft report on the legislation, obtained by POLITICO, would see pharmaceutical companies punished if they don’t launch their products in all EU markets.  

The Commission’s idea is to shave two years off the 10 years companies are allowed to sell their drugs without competition from unbranded rivals, adding either one or both of the years of protection back (the exact amount still has to be determined) only if a medicine is launched in all of the EU.

If it works, it’s an elegant solution to the access problem. If a company doesn’t make its drug available throughout the bloc, cheaper generic competitors will. Pharma companies will also have a strong incentive to sit at the table and negotiate prices to reach a timely deal in each of the EU’s member countries, strengthening countries’ negotiating positions and lowering the cost.   

The pharma industry as a whole doesn’t want their current perks messed around with. But it’s smaller drugmakers in particular — which don’t have the money to hire experts to navigate the massively complicated regulatory and reimbursement system of the EU member countries — that complain it will put them at a disadvantage. 

Cracking the riddle of AMR 

In the world of health, antimicrobial resistance is the market failure par excellence. New antibiotics require hundreds of millions, or more, of euros in investment, for a product that then has to be used as sparingly as possible to avoid encouraging more drug resistance.  

For the cold market logic that pharmaceutical companies live by, it’s not a reasonable proposition. It’s not a coincidence that there hasn’t been a discovery of a new class of antibiotic drugs since the 1980s, and that Novartis, Sanofi, and AstraZeneca have all halted their antibiotic research programs in the past five years.  

But the problem is urgent. Infection from the wrong drug-resistant bug can turn a short stay in hospital after minor surgery into a death sentence. A recent study estimates that nearly 1.3 million people died due to antimicrobial resistance in 2019.

The Commission’s favored solution is a juicy incentive: Develop a truly new antibiotic that meets certain efficacy targets and you get a sellable voucher that grants an extra year of protection from generic competition to the drug of your choice. It might not sound like much, but considering that a best-selling drug can top €1 billion of revenue in a year, a lot of money is on the table. 

The giveaway is as popular among the pharmaceutical industry as it is reviled by the public health NGOs, who say it will cost health budgets dearly by delaying cheaper competition for some of the most expensive — and lucrative — medicines. EU countries have also come out against it, making it an uphill battle once the legislative proposal reaches capitals’ negotiating table.  

Curing the incurable 

For some diseases, treatment has advanced in leaps and bounds in the past decade. In the past 12 years, the EU has approved 158 drugs for solid cancers (counting that sometimes the same drug is approved for a different disease). And drug makers have been handsomely rewarded for their efforts. In other areas, such as neurological diseases, progress has been slower.

The result has been that drug makers piled into areas where science is progressing, leaving millions of patients with less-researched diseases without effective cures. Patients suffering from rare diseases — 95 percent of which do not have any treatment — are especially vulnerable. 

The Commission proposes to award medicines that meet “unmet medical needs” an extra year of protection from unbranded competition. In the draft report, this category is defined loosely as diseases where there’s a lack of good treatments, and which have a high burden.

Better data 

Call it the gold standard of clinical science: the comparative clinical trial, which pits a candidate drug against the best known medicine that treats the same disease. The result will tell you whether the new compound is superior to alternatives.

But such a trial is not always possible. A small patient group might complicate things. It could be that a treatment is very promising and it would be unethical to give patients an inferior drug as comparison. And, often, pharmaceutical companies just don’t like the odds of going head-to-head with a rival. After all, the European Medicines Agency doesn’t require that a drug is better than the alternatives, just that it’s reasonably safe and effective.

The Commission wants to encourage these top-quality clinical trials, which would also generate head-to-head data for health systems to use when deciding whether to reimburse a drug, meaning faster decisions. The solution? You guessed it — an incentive: six months of extra protection from competition for companies that carry out a comparative clinical trial.      

What about the rest?  

Those are just the biggest, boldest initiatives. Others go from the more prosaic — putting multiple languages on medicines packets or making boxes of antibiotics smaller — to the more technical, like forcing companies to conduct follow-up studies or encouraging medicine repurposing. The crucial question of drug shortages, a problem plaguing Europe in recent months, is also addressed, with the Commission wanting to make companies prepare back-up plans in cases of supply disruption.

All of this will seriously upend how the bloc regulates an industry responsible for 1.4 percent of the bloc’s GDP. Given the size and the importance of the market, it’s no surprise that there has been a frenzy of lobbying in the run-up to publication. The industry hasn’t been shy about what it likes and doesn’t like in the proposal. And if the MEP-sponsored letters are anything to go by, Big Pharma has friends in high places. Civil society groups launched their own offensive to pressure the Commission not to give drug makers too sweet of a deal.

Of course, the proposal’s publication in March is only the start. It will then be up to the European Parliament and the Council of the EU to have it out. And if the current temperature of the debate is anything to go by, expect sparks to fly.