A study in Germany, France and the Netherlands highlights an alarming trend: the majority of medicines granted marketing authorisation has no added therapeutic value (ATV) compared to medicines already on the market. In some cases the new medicine even did more harm than good
New Medicines: For Better or Worse?
by Ella Weggen*
Health Advocate, Wemos Foundation
A study in Germany, France and the Netherlands highlights an alarming trend: the majority of medicines granted marketing authorisation has no added therapeutic value (ATV) compared to medicines already on the market. In some cases the new medicine even did more harm than good.
These are the results of a research conducted by Wemos and EPHA. The figures are based on evaluations of several international drug bulletins.
The French drug bulletin La Revue Prescrire has done an analysis of new medicines on the French market over the last ten years and found that less than 25 per cent of them represented a therapeutic advance, including very minor advances. Over 50 per cent of the new medicines represented no advance at all and an average 15 to 20 per cent were judged to do even more harm than good.
In Germany 78 judgments were made between January 2011 and September 2013, revealing that 1 per cent of the medicines evaluated had less benefit than existing treatments (- -), 55 per cent had no additional benefit (-), 24 per cent had minor additional benefit (+/-), 12 per cent had considerable additional benefit (+) and 0 per cent had major additional benefit (++).
From September 2000 to February 2014 the Geneesmiddelenbulletin (Dutch Drug Bulletin) reviewed 112 new medicines, mainly relevant for primary care. It appeared that 1 per cent of the medicines had less benefit than existing treatments (- -), about 50 per cent had no additional benefit (-), about 45 per cent had a doubtful additional benefit (+/-), 4 per cent was judged a useful medicine (+), and 0 per cent had major additional benefit over the current existing arsenal (++).
Current European regulations do not require new medicines to be compared to nor to be better than the prevailing alternative in order to be granted access to the EU market. Thereâs a perverted incentive for the pharmaceutical industry to develop medicines that are similar to ones already on the market. This is cause for concern because it means that public money is being spent on new, costly medicines which have limited added therapeutic value, while urgently needed medicines such as antibiotics are failing to be developed. This fact is especially alarming in the context of the current economic crisis. Often only large injections of public funds or the promise of patent extensions persuade the pharmaceutical industry to develop medicines with a less interesting commercial profile. This means European citizens pay twice; they pay a high price premiums for unnecessary, low ATV medicines through insurance whilst paying for the development of the medicines they really need through taxes. It is time that EU citizens get their moneyâs worth.
Wemos and EPHA find that it is in the interest of the European citizen that added therapeutic value is more prominently addressed in market authorization and reimbursement policies. Together with the International Society of Drug Bulletins and SOMO they have issued a position paper.
*Ella Weggen is a global health advocate working on Wemos’ Governance for Global Health Project. She works on medicines, harmful substances and nutrition. Within the medicines project the focus is on ethical testing in low and middle income countries and Added Therapeutic Value of Medicines on the European Market. In addition she works on the double burden of malnutrition and (endocrine disrupting) chemicals. As a lobbyist she looks at the role of governments in all policy areas, for example in trade negotiations. With a background in European politics, Ella has experience in policy processes at the national, European and international level.