New Medicines: For Better or Worse?

 

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?

Risultati immagini per ella weggen, jpg picture

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. There’s 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 money’s 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.


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*Ella Weggen is a global health advocate working on Wemos’ Governance for Global Health Project. She works on medicinesharmful substances and nutritionWithin 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.

Ella studied Political Science and Public International Law in Amsterdam. She worked as an intern at the Ministry of Foreign Affairs and after at the Political Affairs Department of Amnesty International in the Netherlands. Prior to joining Wemos Ella was an assistant in the European Parliament responsible for agriculture and food. In addition to her job at Wemos, Ella is active for the Youth Food Movement and takes part in the board of Amsterdam politics

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Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens

Compulsory licences should be issued to roll out generic versions of innovative HCV drugs. Only generic competition can push down the extortionate prices of these lifesaving medicines, while placing equitable access and public interest before monopolistic pharma companies’€™ business strategies

Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens

by  Daniele Dionisio

Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

A leading cause of liver cancer and cirrhosis, infection by hepatitis C virus (HCV) affects at least 185 million people worldwide, 85% of whom live in low (13%)- and middle (72%)-income countries. Around 15% of Egypt’€™s population, for example, is infected -the world’€™s highest prevalence – while it is estimated that 12 million people in India have hepatitis C.

 Nearly 350,000 people are killed by hepatitis C yearly, where  preventive vaccines are lacking.

And this occurs at a time when at least 1.2 million people in Japan and three million Americans suffer from hepatitis C, while the infection is a major European public-health challenge (between 0.4% and 3.5% of the population in different EU Member States) as the most common single cause of liver transplantation.

Up to last year, the success rate of available treatments was poor, with a ribavirin-interferon combination being effective in less than 50% of patients after a year (while being fraught with important side effects), and directly acting newer drugs not exceeding 75% sustained response without fully eliminating the need for ribavirin-interferon therapy.

But in recent months innovative medicines have been approved that can cure most HCV infections and do not require interferon in many cases. By directly blocking essential steps for HCV to replicate, they have shown convincing efficacy, mainly when used in combination (functional cure rates in excess of 90% after 12 week treatment), with a good safety profile. These medicines include Bristol-Myers Squibb daclatasvir(Daklinza®), Gilead sofosbuvir (Sovaldi®), Janssen simeprevir (Olysio®), and Bristol-Myers Squibb asunaprevir (Sunvepra®).

And new entries are expected soon, now that big companies are increasingly engaged in bids and acquisition deals to procure new components for more effective, powerful combination regimens. As an example,  Merck will buy the biotechnology company Idenix Pharmaceuticals for $3.85 billion, aiming, as reported, to add a drug from Idenix to its own combination of two agents and develop a once-a-day pill for all C virus subtypes in as little as four week treatment.

Needless to say, the high prices the companies are paying for such endeavors will eventually be over-rewarded by the billions of dollars in annual sales a successful drug regimen could secure. Purportedly , Sovaldi® already helped Gilead rake in, since its debut last December, about $2.3 billion in the first three months of this year, in compensation of $11 billion the company spent  in 2011 to obtain the rights tosofosbuvir through its acquisition of Pharmasset.

Good news for big pharma profits, these circumstances turn into bad news when it comes to prices the manufacturers apply for a 12-week course of each breakthrough regimen. Nothing less than scandalous,estimated prices, averaging from $133,000 to $200,000 for a two-drug new combination regimen (against trifling production costs!), definitely impair affordability and put these drugs beyond the grasp of most of the 90% of hepatitis C patients in low- and middle-income countries where a 12-week course of treatment should cost no more than $500, as firmly believed by Médecins Sans Frontières.

What’€™s more, following inclusion of these drugs in April 2014 WHO treatment guidelines for hepatitis C virus, the cost issue has become all the more critical for national budgets in the resource-limited and affluent countries as well.

As such, it comes as no surprise that, according to allowances in India’€™s Patent Law as regards lack of real innovation, oppositions  were recently filed with the competent authority in India against granting  Sovaldi®  a patent.

As an effect of the mounting pressure against prices out-of-reach for national health insurances, big pharma has begun negotiating bilateral agreements and voluntary licence (VL) deals with country governments and generic manufacturers. In the Gilead cases with Egypt and India, Sovaldi® has been priced at $900 for a 12-week course, and negotiations are in progress with Indian manufacturers to produce generic sofosbuvir.

Unfortunately, as reported, while the price agreed with Egypt would rank beyond the reach of the domestic health budget, voluntary licence negotiations with India are feared to exclude export to many middle-income countries with high HCV burden.

Likely, this is not happening by chance at a time when international donors are cutting support to middle-income economies and the brand industry is eagerly looking to the fast-growing markets where a number of well-off elites, who can afford out-of-pocket spending (at least 300 million people in India, 800 million in China), now live.

Admittedly, although VLs, as part of the flexibilities laid down in the World Trade Organization TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, do include permission for export, a number of constraints limit this model basically because the originators actually hold control over the whole manufacturing, distribution and pricing chain of steps: an unbalanced mechanism.

On the contrary, unrestrained competition by compulsory licences (CLs), another flexibility provision in TRIPS, would be a far better mechanism for maximizing the affordability by allowing “…someone else to produce the patented product or use the patented process without the consent of the patent holder”€. 

This would also be the case for an allowance for export agreed upon through a 2003 WTO waiver (the “€œAugust 30th Decision”€) that permits export under CLs to countries unable to manufacture key medicines themselves.

On these grounds, compulsory licences should be issued at once to roll out generic versions of innovative HCV drugs. Only generic competition would be up to pushing down the extortionate prices of these lifesaving medicines, while making equitable access and public interest overcome monopolistic pharma companies’€™ business strategies.

To the point, cheap generic versions of state-of-the-art HCV drugs would reasonably be within reach. Relevantly, published data this year argue that generic-drug makers would be able to roll out these medicines at $100-€“250 for a 12-week course.

Overall, these considerations align with a resolution on hepatitis unanimously adopted by Member States at WHO General Assembly in May.

Among others, the resolution urges Member States …(12) to consider, as necessary, national legislative mechanisms for the use of the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights in order to promote access to specific pharmaceutical products;…

The resolution also requests the Director General  (9) to support Member States with technical assistance in the use of trade-related aspects of intellectual property rights (TRIPS) flexibilities when needed, in accordance with the global strategy and plan of action on public health, innovation and intellectual property;…

  

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*Article republished from Intellectual Property Watch August 5, 2014 http://www.ip-watch.org/2014/08/05/compulsory-licences-needed-for-affordable-hepatitis-c-innovative-drug-regimens/  

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). He may be reached at d.dionisio@tiscali.it  https://twitter.com/DanieleDionisio 

 

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