Billboards, hot letters and alarming interviews in major newspapers – it has become clear in recent months that the pharmaceutical industry in Brussels has something to defend. In the run-up to a package of new drug regulations, companies did their utmost to water down and delay the plans.
The proposal was presented by the European Commission this Wednesday. And the result is not very reassuring for the industry.
The hottest of the plans presented by European Commissioner Stella Kyriakides (Health) is a new incentive to encourage pharmaceutical companies to immediately market new medicines everywhere in the EU. At the moment there are major differences within Europe in the moment that medicines become available. A Polish patient has to wait an average of two years longer than someone in Germany.
To address this, the Commission is shortening the period that companies can sell a new drug exclusively from 10 to 8 years. Unless such a company markets the drug in all 27 Member States: in that case they can regain some extra exclusivity rights. Time can also be gained by addressing an “unmet medical need” or developing drugs that can treat more than one condition. “We cannot have first and second class citizens in the EU when it comes to access to medicines,” said Kyriakides.
The plans, which have been circulating for some time, have recently sparked a fierce lobbying campaign. Large billboards with an American flag and the slogan ‘Mind the Gap’ hung in the European quarter in Brussels. The message was that shortening market exclusivity would put the EU at a great disadvantage compared to the United States.
That was also the message of interviews that pharmaceutical bosses recently gave. Like this turned Eli Lilly’s top man, a large American pharmaceutical company, located in the Financial Times against the “worrying” proposal, which according to the company would lead to much less money being spent on new medicines for Alzheimer’s, for example. “If you think we have enough innovation or too much, this reduction idea will achieve its goal,” said David Ricks.
‘Blind Optimism’
Farm lobby club EFPIA contradicted Politico of ‘naivety and blind optimism’ that would lead to ‘extreme damage to European competitiveness’. Germany also joined the fight, calling for the ‘entry requirement in exchange for exclusivity’ to be dropped, as did several MEPs.
Yet little has changed in the package presented on Wednesday, which illustrates that the importance of accessible healthcare in Brussels has moved higher on the agenda. Moreover, the Commission emphasizes: market protection for new medicines is still stronger in Europe than in the US or China.
Rosa Castro of EPHA, the umbrella organization of more than ninety healthcare and patient organizations in the EU, does not dare to say whether the covid pandemic and the influential role of pharmaceutical companies in vaccine supplies now play a role in the discussion. “The arguments of the big pharmaceuticals are really very traditional – with the eternal threat to leave Europe.” However, Castro also notices that accessibility and fairness of healthcare are considered more important in Brussels. “The Commission has been working on this for some time, but the pandemic has put the importance of accessibility and fair prices in the spotlight. Just like the risk of shortages.”
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Mandatory licenses
The Commission also wants to tackle the latter with the plan presented on Wednesday. Pharmaceutical companies are required to monitor stocks better and to signal impending shortages – measures that were also taken during the covid crisis, but are now permanent. Pikant is also a new proposal to make it easier to use compulsory licenses for the production of vaccines and medicines in times of crisis – something that has only been threatened during the pandemic.
To tackle antibiotic resistance, the Commission wants to encourage pharmaceutical companies to develop new antibiotics. In exchange for such a new drug, they can receive a ‘voucher’ that gives them an extra year of market exclusivity for another drug they produce – and thus earn more money.
The hard lobby of recent times has not been completely without effect: it also led to the package presented on Wednesday being postponed numerous times. This is less innocent than it seems: as the European elections approach, there is a growing risk that a legislative proposal cannot be finalized before the end of this term, next spring. And that causes even more delays, because a new Commission and a new European Parliament then have to work on the file.