Toby Sterling -
In a radiation-proof room at the Erasmus Medical Center in Rotterdam, Emar Thomasa sits behind shielded glass as he carefully measures and mixes lutetium octreotate, an intravenous treatment for certain types of cancer.
The Dutch hospital has been offering it to patients for more than a decade at 16,000 euros ($18,000) for one course of treatments. Drug firm Novartis, which in 2018 acquired rights to sell it in Europe, is asking more than five times that for its proprietary version, Lutathera.
Thomasa is part of a protest against high drug prices launched by an unlikely group of rebels: Dutch pharmacies.
Three — Erasmus, Amsterdam’s University Medical Center (UMC) and the Transvaal Pharmacy in The Hague — have vowed to bypass drug company products and make treatments for a handful of rare diseases themselves, exercising their right to “compound” medicines.
The Dutch market is small, with only hundreds of patients for the diseases in question. But the dispute is part of a growing global backlash against high drug prices, from the United States and Canada to Japan, and campaigners said it was being closely watched by health experts elsewhere.
“People with rare diseases are dependent on medicines that are so expensive that they can’t afford them, when they could be offered for a much lower price,” said UMC pharmacist Marleen Kemper.
“The pharmaceutical industry plays an important role in developing good products, but we think it’s not fair if these firms make big money off these patients.”
Compounding is the ancient practice of preparing medicines for individual patients. Pharmacists are trained to compound, though nowadays most medicines are made by industrial producers.
Drug companies have raised concerns about the safety of compounded medicines that have not been approved by European regulators. But the specialised compounding pharmacies, which have on-site laboratories, have been backed by the Dutch government as part of efforts to tame rapidly rising medicine costs.
UMC received a 5-million-euro grant last month to expand its compounding programme. It plans to use the money to set up a centre to swap know-how with pharmacies at home and abroad.
The drug industry, including Swiss giant Novartis and Italian-based Leadiant, argue Dutch national supervision of pharmacy preparations is not comparable to the European standards that apply to pharmaceutical companies.
A spokesman for Leadiant said when Dutch patients suffering from rare diseases were exposed to medicines that had not been subject to the stringent testing required of authorised drugs, it could have “significant repercussions” for their health.
Novartis CEO Vas Narasimhan said the price his company asks for Lutathera is justified. He said it was impossible to compare the treatment made at Erasmus with Lutathera, which received approval from EU watchdogs after proving it worked in its exact formulation.
The potential perils of compounding were shown in 2012 in the United States, where the market is more developed. A meningitis outbreak that killed more than 60 people was traced to contamination in steroid injections made at the New England Compounding Centre, which was then overseen by Massachusetts state regulators.
GLOBAL BACKLASH
The worldwide push against high drug prices has seen the Trump administration in the United States declare bringing down prescription prices a top priority.
In Canada, industry lobbying groups have offered concessions as they seek to avert a government crackdown. And in Japan, regulators are considering a cost-effectiveness test as a means of capping prices.
The Dutch pharmacies, whose production is on a small scale, acknowledge they may face legal challenges from the drug industry. However, such a case could set a precedent for other European countries.
The Netherlands has an influential voice in Europe as the seat of the European Medicines Agency, which scrutinises and approves drugs for all EU countries. The EMA has moved to Amsterdam as a result of the Brexit vote.
Pharmacies retain the right under European and American law to prepare medicines for individual patients. Common examples including making lower dosage versions for children or liquid versions for people with difficulty swallowing.
However, in the United States, for-profit compounding pharmacies have tested the limits of what they are allowed to do in recent years, including mixing medicines in large quantities. In some cases, that has prompted legal conflicts with drugmakers.
Official scrutiny of the practice increased after the 2012 deaths in Massachusetts, which led to US lawmakers requiring bulk compounding facilities to register with the Food and Drug Administration (FDA) and meet quality and labelling standards — still not as stringent as full FDA drug approval.
Els Torreele, who oversees the Doctors Without Borders Access Campaign, applauded the Dutch pharmacies’ move. She said the developments in the Netherlands were being followed by medical experts and politicians in other countries, which could follow a similar path.
Torreele said big pharmaceutical companies sometimes lost sight of the fact that rules granting them exclusive manufacturing rights for new drugs were intended to foster innovation, not guarantee large profits.
“If (drug companies) can play a role in providing medicines at an affordable price, fine, but when they become a barrier, then there’s a problem,” she said.
Dutch Medical Care Minister Bruno Bruins attended the opening of a new compounding laboratory at the Transvaal pharmacy in January. His government has vowed to curb drug price increases, a pledge welcomed by the public.
Costs for new medicines in the Netherlands rose 9 per cent in 2018, according to a report by the country’s Heath Authority, continuing a multi-year trend.
“We need drugmakers like Novartis for medicines now and the medicines to come,” Bruins said. “We really can’t do without them. And yet we want them for a reasonable price.”
— Reuters
Oman Observer is now on the WhatsApp channel. Click here
