Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

	In the last five years, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized counterfeit drugs worth more than £25 million ($41 million), but the war isn’t over yet. Counterfeit products are still a threat to the UK, which is why the agency has launched a new anticounterfeiting strategy called the 

Falsified Medical Products Strategy 2012–2015

. The strategy includes several measures centred around prevention, incident management and investigation.

The MHRA will implement this using a combination of market surveillance and testing, vigilance at UK ports, pharmacovigilance and establishing networks to facilitate exchange of information and cooperation. In addition, the agency will communicate the danger of counterfeits.

Upon receiving a report of counterfeit medicines, the MHRA’s immediate action will involve conducting an initial assessment quickly, with the focus, of course, being on minimising the risks to public health. Working relationships with relevant public or private entities will be crucial.

 All cases involving reports of falsified medical products to the MHRA are investigated, particularly with regards to where the product came from and then tracing payments through bank accounts. The MHRA believes that prosecution and confiscation of any financial proceeds from counterfeit medicines is one way of making fake medicines a less attractive option for criminals.

	This is the second such strategy that the MHRA has implemented. The first was launched in November 2007 following several incidents of falsified products entering the UK’s regulated supply chain. A significant supply chain breach occurred in early 2007 when more than 2 million doses of fake medicines for the treatment of prostrate cancer, heart disease and schizophrenia were imported into the UK under the guise of parallel-traded products. Of these, 700,000 reached pharmacies and patients.

	Traditionally, counterfeit medicines have been most prevalent in developing countries where supply chains tend to be less regulated. Several initiatives have been launched to try and curb the occurrence of counterfeits, but it’s frightening to hear that counterfeiters are adapting accordingly and even learning how to get their products into the heavily regulated supply chains of Europe and other industrialised countries. Recently, for instance, counterfeit Avastin was found in the US.

	Fortunately for those of us in developed countries, it’s rare that counterfeit products reach patients via the legitimate supply chain. In the UK, there have been 10 instances of counterfeit medicines reaching the pharmacy and patient level since 2004, and the MHRA added that the incidents of such medicines has declined since 2007. One of the main sources of counterfeit medicines, however, is illegal websites. The World Health Organisation has 

that 50% of medicines available from sites that conceal their physical address are counterfeit, and there are thousands of these websites. In two different anticounterfeiting operations involving the MHRA in 2010 and 2011, around 14,000 websites advertising fake medicines were taken down or suspended. The operations also resulted in the seizure of more than 4.5 million doses of counterfeit medicines.

	In recent years, the MHRA has also reported on several successes in battling counterfeit medicines. In 2008 and 2011, for instance, falsified medicines were intercepted at the wholesale level before they reached pharmacies. Most recently, Simon Martin Hickman was 

 to pay a confiscation order of £14.4 million ($23.4 million). Hickamn was convicted in 2009 for selling and supplying fake and unlicensed medicines, and money laundering to the value of £1.4 million ($2.3 million).

Articles

In the last five years, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized counterfeit drugs worth more than £25 million ($41 million), but the war isn’t over yet.

Anticounterfeiting Success in the UK

GlaxoSmithKline has reached an agreement to divest certain over-the-counter (OTC) brands in select territories to South Africa’s Aspen Pharmacare Holdings for approximately $264.7 million. 

According to GSK, the divestment will allow the company to focus on priority brands and markets. Divested brands include Phillips MOM, Solpadeine, Dequadin, Cartia, and Zantac, which generated combines sales of around $96.8 million in 2011. The divestment will be completed in the second quarter of this year, following the necessary regulatory approvals. 

The agreement comprises two transactions. The first is Aspen Holdings’ acquisition of products sold in South Africa, Mabbia, Botswana, Swaziland, Lesotho, Zambia and Zimbabwe. The second transaction is Aspen’s acquisition of the products sold in the rest of the world, but excluding Europe and North America, which are the subject of separate transactions between GSK and third parties. 

“The products acquired through these transactions are an excellent geographic fit with Aspen’s existing footprint and will allow for significant strengthening of Aspen’s OTC offering in all of the territories concerned,” Stephen Saad, chief executive of Aspen Group, said in a 

. “The products have considerable established brand equity, which Aspen intends to leverage through increased promotion and plans to expand through line extensions.

Aspen is funding the transactions though existing cash resources, existing credit facilities and new debt, with the latter funding approximately 50% of the transaction. The company has already made arrangements for raising the new debt.

, GSK added that it also plans to divest alli, but the process has been delayed pending the resolution of a temporary third-party supply interruption.

GlaxoSmithKline has reached an agreement to divest certain over-the-counter brands in selected territories to South Africa's Aspen Pharmacare Holdings for approximately $264.7 million.

GSK Divests OTC Brands Worth $264.7 Million

Merck KGaA has revealed further details about its previously announced restructuring program, including plans to eliminate approximately 580 jobs. A further 750 positions will be transferred from Switzerland to alternative sites primarily in Germany, the US, and China.

The company will close its Merck Serono headquarters in Geneva, Switzerland, and consolidate all headquarters functions in one site in Darmstadt, Germany. Of the current 1250 current positions in Geneva, 500 will be cut to eliminate duplications and the remaining 750 positions will be transferred. The aim of the transfers is to leverage scientific expertise in the biotechnology hub of Boston, Massachusetts, and to ensure clinical development in all key growth areas.

Despite the Swiss closure, Merck added in its 

 that it intends to maintain a manufacturing and marketing presence in Switzerland. Currently, the company operates three manufacturing sites in the country in Aubonne, Corsier-sur-Vevey, and Coinsins. As part of the restructuring, operations in Coinsins will be transferred to the Aubonne site, and 80 jobs across all three sites will be eliminated. Out of the 750 jobs that will be transferred, more than 130 positions related to technical manufacturing in Geneva will be moved to Aubonne. The company also intends to maintain its Swiss market operations in Zug.

“The planned measures for Merck Serono’s operations in Switzerland are needed to ensure our global competitive position in a rapidly changing market and to secure the long-term future of the company,” Stefan Oschmann, executive board member of Merck and responsible for the Merck Serono division, explained in a statement.

Merck first announced the restructuring plan, and warned of upcoming workforce reductions, 

Merck KGaA has revealed further details about its previously announced restructuring program, including plans to eliminate approximately 580 jobs.

Merck KGaA Announces Job Cuts

The European Commission (EC) is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability. According to the EC, the need to keep vaccines stable at any ambient temperature is a huge barrier to using vaccines in developing countries or tropical climates. The prize was announced at the third Innovation in Healthcare conference in Brussels by the Research, Innovation and Science Commissioner Máire Geoghegan-Quinn.

, Geoghegan-Quinn said: "Many people in tropical and developing countries cannot benefit from life-saving vaccines as these vaccines are damaged before they can reach them. The goal of this prize is to galvanize scientists into producing innovations which can solve this global health problem."

Vaccine delivery from manufacturers to recipients can take 18 months. During this time, most vaccines must be kept at a constant, suitable temperature. Often, this requires an unbroken cold chain, but such a system can be difficult to implement in developing countries, which means vaccines are often rendered ineffective before they reach their recipients. In a statement, the EC quotes the World Health Organization’s claim that half of all supplied vaccine doses are wasted — mainly by an inadequate cold-chain. 

The winner will be announced in 2013, and must convince a panel of judges that vaccines can be safely transported and stored in field conditions such that they retain their full potency, effectiveness and safety. In addition, the solution should be able to be implemented at reasonable cost. 

In Europe, funding worth EUR 400 million ($529 million) has already been awarded through Research Framework Programs 6 and 7 for projects relating to vaccine research. However, cold-chain technology has never been a focus of either of the framework programs.

The European Commission is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability.

EC Offers Cash Prize for Vaccine Stability

	The past month has seen a lot of news about the pharmaceutical industry’s positive influence in developing countries, and this progress looks set to continue thanks to initiatives being launched by the World Health Organization (WHO) and the European Commission (EC).

 a new plan that aims to completely eliminate measles and rubella. Key to the success of the plan will be vaccination. According to the WHO, measles deaths have reduced by 74% between 2000 and 2010 thanks to vaccines. Now, the WHO wants to go a step further by introducing rubella vaccines too. By 2015, the plan intends to cut deaths by 95% compared with 2000 levels, and to completely eliminate measles and rubella in at least five WHO regions by 2020.

	The initiative, named Measles & Rubella Initiative, has received strong support from the GAVI Alliance, which obtains vaccines from the pharma industry at subsidized prices for use in vaccination campaigns in developing countries.

	Meanwhile, earlier this month the European Commission 

 a €2-million prize to encourage researchers to overcome one of the main barriers to using vaccines in developing countries: the need to keep them stable at any ambient temperature.

	Vaccines used in tropical and developing countries are often rendered ineffective by temperature variations during transport and storage long before they reach their intended patients. The EC believes that solving the challenge of vaccine stability could go far in aiding the vaccine efforts of developing countries and an inducement prize could be just what’s needed given that innovations such as tinned food, transatlantic flights and navigation at sea were all encouraged via competitions and prizes.

	Of course, it’s all very well for the WHO and the EC to launch these initiatives but support from the pharmaceutical industry is vital. Fortunately, many pharma companies are already on the case.

	Last week, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a

 announcing that more than 300 vaccines are currently in development in the US. As well therapeutics of interest to the west, such as cancer vaccines, the list also includes a vaccine for protecting infants against meningococcal disease, a leading cause of meningitis and a recombinant vaccine to prevent malaria.

	Big Pharma names have also been in the headlines for their efforts in developing countries. At the end of last month, for instance, Christopher A. Viehbacher, CEO of Sanofi, took a trip to Africa to see the work the company is conducting to support the fight against neglected tropical diseases, such as sleeping sickness. According to a 

, Sanofi and its partners are on track to eliminate this disease by 2020.

	Other big-name companies are also pursuing projects in the developing world. For example, in March, the UK’s University of Dundee announced that it had received more than £10 million to work with GlaxoSmithKline on treatments for tropical diseases, including Chagas disease, leishmaniasis and sleeping sickness.

, a huge coordinated push to fight neglected tropical diseases was launched by several global health organisations and pharmaceutical companies. No doubt we will be hearing more about pharma and neglected diseases in the future.

The past month has seen a lot of news about the pharmaceutical industry’s positive influence in developing countries.

Pharmas Efforts in Developing Countries

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials. The paper applies to trials conducted outside of the EU and the European Economic Area that are submitted in marketing authorization applications to European regulatory authorities, with the aim of ensuring that all trials, no matter where they’re conducted, meet the required standards.

The framework provided in the paper applies to medicines for humans and enters into force on May 1, 2012.

 from the EMA, the increasing globalization of pharmaceutical R&D has created a significant challenge for regulators.

“...no matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting,” explains the EMA statement. “Yet regulators, healthcare professionals and patients worldwide all rely on the same trial data when making decisions on whether to allow a medicine on the market or not and on whether to use a medicine or not.”

The reflection paper addresses this challenge by outlining concrete steps for international cooperation in the regulation of clinical trials, with an emphasis on initiatives that will allow for a common approach to the oversight of trials. In addition, the paper will help assure regulators that ethical and GCP standards are applied to trials, both during development and the marketing authorization application phase.

Clinical trials that are conducted outside of the EU and submitted in marketing authorization applications to European regulatory authorities must meet the same ethical principles and standards that are required of trials performed within EU borders. To achieve this, the paper highlights the importance of independent local ethics committees in the oversight of clinical trials, as well as the necessity of obtaining trial participants’ consent.

The reflection paper follows an extensive public consultation, and has been endorsed by the EMA’s Committee for Medicinal Products for Human Use, the Coordination Group for Mutual Recognition and Decentralized Procedures – Human, the management board of the EMA and the Heads of EU Medicines Agencies.

GSK in Spotlight for Alleged Unethical Trials

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials.