#EAPM: Italy drug scandal highlights access to medicines issues

In the wake of a pharmaceutical pricing scandal in Italy, renewed calls have been made for the European Commission to investigate ‘unethical’ practices, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

As a result of complaints made in 2014, drugmaker Aspen Pharma was fined €5.2m on 14 October for abusing its dominant position in the cancer-medicine market, and effectively blackmailing the Italian regulatory agency (AIFA).

Italian anti-trust authorities found that the South African company, which purchased the out-of-patent cancer drugs from GlaxoSmithKline (who are not implicated), threatened to interrupt the supply of four vital medicines if AIFI did not accept price increases ranging from 300% to 1,500%.

Now there have been ever-louder calls for an EU-wide investigation into possible links between inflated prices and shortages of medicines.  In its statement, AIFA called the drugs "life-saving and irreplaceable". It described the negotiation strategy adopted by Aspen as “so aggressive as to reach the credible threat of interrupting the di-rect supply of the drugs to the Italian market”.

The oncology medicines in question are vital for patients in Italy, especially children and the elder-ly, and AIFA added that the pharmaceutical company was the only supplier of this type of anti-cancer drugs, had abused its market position and that the fine concerned “fixed unfair prices”.

Giovanni Codacci-Pisanelli, assistant professor in medical oncology at the University of Rome, said: “One of the main criticisms against Aspen Pharma is that they did not ask for an updating of the drug price using the available legal instruments, but rather chose aggressive behaviour that jeopardized the availability of these life-saving and irreplaceable agents.

“Furthermore, this behaviour is absolutely not justified by the need to get back the price of re-search. Aspen Pharma did not do any research, but only recently acquired these molecules presumably with the explicit aim of making an unjustified profit by a sharp increase in their price.”

He added: “The soaring price of new treatments (anti-cancer agents but also new drugs for hepati-tis) may cause relevant problems in all countries that provide state-based healthcare assistance to their citizens.

“What we need is a form of collaboration: pharmaceutical companies have a right to make profit, the state - and therefore its citizens - has a right to obtain access to effective treatments at an ac-ceptable price. Saying that 'good health is priceless' is unreasonable and not sustainable, and may only lead to negative results.”  He described the decision by the Italian competition authority as "a welcome step”.

Consumer group Altroconsumo, meanwhile, said the medicines: “Disappeared from the market af-ter Aspen Pharma acquired ownership, then reappeared at higher prices.”

Altroconsumo is a member of the Europe-wide consumer advocacy network BEUC. The umbrella organization’s Head of the Food and Health Department Ilaria Passarani said: ”We are dismayed by this kind of pernicious practice which puts profits before consumers' health. The impact on con-sumers is not only serious but also unjustified.

“We are talking about life-saving anti-cancer drugs being withdrawn from the market and reintro-duced with an unaffordable price tag. The impact on consumers is not only serious but also unjusti-fied,” Passarani added.

BEUC has called on the Commission to launch a probe into medicine shortages. The purpose of any such investigation would be to examine whether these shortages are being used as a tactic to up prices to member state health authorities.

The consumer organization has called such practices “unethical”.  In its ‘Access to Medicines’ of 2015, BEUC states: “Access to medicines is a growing concern for European consumers. A number of recent developments including the economic crisis, the ageing population, technological advances, increased consumers expectations and new health threats present major challenges for sustainability of national health care systems and the medicines they provide.”

It has made several recommendations, including that profits should be balanced with affordability, especially when public money has funded drug research and, crucially that antitrust authorities at EU and national levels should continue to monitor potential anti-competitive practices to protect consumers from artificially high drug prices.

The position paper adds that: “More investigation and transparency on the causes of shortages and more information to the general public on the implemented solutions are needed.”

On its website the European Commission states that it “ensures fair competition in pharmaceutical, health services and medical devices markets. When pharmaceutical companies, medical devices companies or other health-related companies are deterred from unfair competition, citizens win”.

It adds: “The market for medicines is highly regulated within each country. National pricing and reimbursement rules for medicines are not harmonized within the single market. This leaves less room for competition on prices and so market forces cannot realize their full effect here as they do in most other industry sectors.”

The EU executive goes on to state that it has launched various initiatives to ensure that pricing and reimbursement systems across the EU are closely linked to the realisation of EU policy objectives”.  In a long report on medicine pricing in Europe, the Commission looked into two policy options: ex-ternal price referencing (EPR), which is a tool for medicine price control and currently employed across the EU, and differential pricing, which is a strategy to improve access to otherwise unaf-fordable medicines.

EPR is defined as “the practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of a medicine in a given country.”

Meanwhile, in June of this year, EU Health ministers noted that there is a market failure in many cases where patient access to effective and affordable essential medicines becomes problematic. This is down, they said, to “very high and unsustainable price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic strategies”.

The ministers added that “individual governments have sometimes limited influence in such cir-cumstances”.  In recent times, the European Commission has been blamed for a “low” political appetite when it comes to addressing the situation.

Share this article: