International treaty signed to combat growing counterfeit drug industry

According to a report by The Moscow Times, many European leaders have recently agreed to cooperate in the fight against counterfeit medicines:

Convention to Combat Fake Medicine Signed

(Moscow Times)  Russia, France, Germany and several other mostly European countries on Friday signed the first-ever international treaty to combat the growing multibillion-dollar counterfeit drugs industry.

The Council of Europe-sponsored Medicrime Convention, signed in Moscow, obliges signatory states to criminalize a broad range of activities that make possible the sale of fake medicines that harm patients and deprive legal producers of revenues.  The convention introduces minimum standards for the criminal law of the signatory countries, said Council of Europe media officer Estelle Steiner.

Ambassadors and diplomats of Austria, Finland, Italy, Israel, Iceland, Portugal, Switzerland and Ukraine have signed the treaty. It establishes as criminal offenses such activities as the manufacturing of counterfeit medical products (including equipment), their supply and offers to supply, trafficking and the falsification of related documents.

Many fake drugs contain an insufficient amount of active ingredients, which could cause fatal consequences for the patient.

According to the World Health Organization, counterfeit medical products represent between 6 percent and 20 percent of the market in some parts of Europe.

 

Modern lifestyles increasing risk of NCDs

Modern lifestyles and demographic changes are increasing the risk of noncommunicable diseases (NCDs): cardiovascular diseases, cancers, chronic respiratory diseases and diabetes.  Each year they account for 60% of all deaths or some 35 million people. (Source:  World Health Organization)

The four most prominent NCDs – cardiovascular diseases, cancer, diabetes and chronic lung diseases – were recognized as the key health priority in the WHO European Region at a recent WHO European Region meeting.  NCDs account for 77% of the disease burden and 86% of all deaths in the 53 countries in the WHO European Region.

The WHO notes that in addition to their impact on public health, NCDs constitute an economic burden, with health care costs, lost working time, and early death and disability threatening economic growth and productivity.

Cutting drug prices hampers innovation: study

Cutting pharmaceutical prices in the way European governments are doing now will severely reduce the number of new drugs making it to market.  There is a direct link between strict regulation and low innovation in the sector, according to a study by a Berlin-based European School of Management and Technology Competition Analysis (EMST CA) and commissioned by the drugmaker Novartis (download a PDF of the full study).

The EMST report said that while European governments predominantly see pharmaceutical pricing models as a way of controlling public health costs, they may not realize or acknowledge the implications for product value, and therefore for the development of new drugs.

The report goes on to argue that current pricing models “are often shown to favor ‘breakthrough’ pharmaceutical innovations over ‘follow-on’ drugs, or incremental improvements”.  This can lead to ‘a different understanding of innovation for patients and chemists’, the study states.

For example, a statin may be redeveloped to have fewer side effects or be more beneficial for one group of patients and while this will seem like an innovative development to the patient, “it will not necessarily be innovative enough from the pricing regulator’s point of view to benefit from favorable regulation”.

The report concludes by saying that the analysis “demonstrates the need to support both ‘first in class’ and ‘best in class’ products, rather than drawing a regulatory distinction between ‘breakthrough’ products and everything else”.

Italy cuts generic drug prices – to save 600 million euros

Italy is taking new steps to rein in healthcare spending by imposing a cut in generic drug prices – estimated to save the country 600 million euros ($733.8 million).

Under a package of measures, the price of off-patent generic drugs will be cut by 12.5 percent from June 2010 until the end of this year.  From 2011, reimbursement of generics will be limited to the cheapest version of a medicine within four therapeutic categories, with the lowest price established by a tender system. Purchases of goods and services by the state health service above reference prices will have to be justified.

The introduction of a tender system for purchases of generics follows similar action by Germany.

(Source:  Reuters)

Internet drug sales to be included in new EU legislation aimed at preventing counterfeits

European parliamentarians voted yesterday in favor (51-0) of including Internet drug sales in European Union (EU) legislation aimed at preventing counterfeit medicines from entering the supply chain.

Under the proposal, Internet pharmacies would have to obtain special authorizations in EU member states where they are allowed to operate. Their sites would be required to bear a EU logo to indicate that they are linked to an authorized pharmacy, and they would be listed in a European database.

Mandatory safety features such as seals or serial numbers would be required for prescription medicines, although this obligation could be waived, for example in the case of generics, subject to an assessment by the European Commission.

They have also called for stronger sanctions against drug counterfeiters, supporting proposals from the Council of Europe to make the trade a criminal offence.

The European Parliament is due to vote on the Falsified Medicines Directive in July.

Update on EU leadership

The following update on the election of a new EU executive and it’s impact is provided by the European Public Health Alliance.

With the announcement of ’Barrosso II’, all that remains between a new political leadership in Brussels is the Parliamentary hearings. The designated Commissioners are busy preparing for the scrutiny before the European Parliament, a gruelling three hour process where questions are mooted on potentially any topic within their portfolio. This is not the simple ’rubber stamp’ procedure that it may appear : Commissioners are expected to understand the details of the political and technical dossiers and prepare for the most challenging and divisive questions. The new Health and Consumer Commissioner, John Dalli, is in for a particular challenge. Always a broad portfolio, the inclusion of biotechnology, pharmaceuticals and medical devices, cosmetics and genetically modified organisms gives not only far more technical and complex dossiers but also those with heavy economic interests and strong positions. All will be watching the hearings, in order to get a sense of the leadership for the next five years.

Meanwhile, Brussels waits. The political dossiers are on hold : big consultations on issues of key interest and impact are waiting for the political leadership to take the helm. The EU2020 consultation, on the future business plan of Europe, is however underway, with a deadline of 15 January. This short consultation, for what is the second most important document in terms of decision-making after the Treaty, coinciding with the Christmas holidays is causing many in Brussels to call in protest at the challenges this brings for a full and transparent debate of the issues.

EU announces new ‘single patent’

The Council of the European Union (EU) has announced an agreement on long-awaited plans for a single EU Patent and a new European patent court.  The EU Patent will involve partnerships between European patent offices, which will bring about more rapid delivery of patents and increase speed of access to market for innovative products and services.

The proposed EU Patent will make it less costly for businesses to protect innovative technology and make litigation more accessible and predictable, says the EU Commission.

EU: Seizures of counterfeit imports double in 2008

The European Union said seizures of fake branded goods more than doubled last year from 2007.  Customs authorities seized some 178 million counterfeit goods last year, compared with 79 million a year earlier.

Some 20 million of these items were potentially dangerous to health and safety, officials said, because fake toys, medicines and electronics don’t meet EU standards.

While China was the main source of fake goods overall, Indonesia was the main supplier for fake food and drinks, the United Arab Emirates for counterfeit cigarettes and India for medicines.

Explosion in drug websites puts patients at risk

An investigation by the Telegraph (London, UK) revealed that hundreds of websites, many based in Britain, are selling dangerous drugs which should only be prescribed by doctors.

The Telegraph’s investigation revealed websites selling dangerous drugs with few or no checks.

The law states that patients buying drugs over the internet must first undergo a full online “consultation”.  Several websites based in this country remained within the law by insisting on a free “consultation” with a doctor registered with the General Medical Council – essentially, a basic online quiz – before supplying prescription drugs.  Yet in some cases they failed to ask for crucial details necessary to identify risks to the patient.

Other websites, hosted in Asia, Russia and Eastern Europe offered a range of drugs with serious side effects at the click of a button with no checks whatsoever.

According to unpublished figures compiled by the MHRA, 500 cases have been referred to UK regulators because sites were believed to be operating illegally, including sites selling counterfeit drugs.  In more than 400 of the cases the websites were found to be hosted abroad, beyond the reach of British prosecutors.

Many offered pills known to carry serious risks, such as the slimming drug Accomplia, which was taken off the shelves of British pharmacies last October after regulators ruled that its risks, including that of serious psychiatric disorders, outweighed any benefits.

Read the full article…

New Pharmaceutical Price Regulation Scheme in the U.K. to Encourage Innovation and Access

A new Pharmaceutical Price Regulation Scheme (PPRS) came into effect in the U.K. on January 1, 2009.  The PPRS represents an attempt to balance incentives for innovation with cost and price restraint.  The objectives of the 2009 PPRS are:

• To deliver value for money; securing the provision of safe and effective medicines at reasonable prices;
• To encourage innovation by promoting a strong and profitable pharmaceutical industry;
• To promote access and uptake for new medicines; and
• To provide a stable and predictable market environment.

“The health departments of the UK and the Association of the British Pharmaceutical Industry have a common interest in ensuring that safe and effective medicines are available on reasonable terms to the NHS, and in a strong, efficient and profitable pharmaceutical industry. Such an industry must be capable of sustained research and development leading to the future availability of new and improved medicines in this and other countries.”
              — Department of Health Site

Some of the important new features are provisions aimed at encouraging and rewarding innovation and encouraging the uptake of cost-effective medicines.