Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The European Medicines Agency has published a plan to help Europe’s regulatory network prevent, mitigate, and manage shortages of important medicines following manufacturing problems. 

Shortages of medicines arising from unforeseen disruptions within manufacturing processes, such as GMP compliance issues, have increased in recent years. However, experience from these shortages has enabled the EMA to identify several short- and medium-term actions that will help to deal with future occurrences. These actions are outlined in the EMA’s reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems. 

Some of the actions being taken in the short term include, among others:

Creating a public catalogue of current shortages

Establishing standard operating procedures for handling reports of shortages

Develop international cooperation to enable information sharing for specific shortages and on best practices on risk management and prevention strategies

Raise the awareness of the impact of medicine shortages and stimulate industry reaction and improvements. 

Facilitate risk–benefit evaluation where risk shortage has to be balanced with potential risk because of the presence of a product defect. 

Require all marketing authorization holders to submit a risk analysis of their manufacturing processes to identify weaknesses, and contingency plans to strengthen these points.

Investigate processes that could be used to measure the impact of medicines in patients. 

Promote better and proactive risk management by marketing authorization holders. 

According to EMA, several trends have converged to increase the number of medicines’ shortage. One of the major contributing factors is the globalization of supply chains and manufacturing networks.

Articles

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

EMA Publishes Plan to Deal with Supply Shortages

Passengers travelling via Air France this December will see an in-cabin movie made by Sanofi to raise awareness about the dangers of counterfeit drugs.

		According to Sanofi’s video, up to 10% of the world’s medicines can be counterfeit. In industrialised countries, counterfeit medicines are rare and many patients and consumers may not be fully aware of the dangers. In other locations, however, such as some countries in Africa, Asia, Latin America and in emerging markets, counterfeit medicines may comprise 20–30% of the market. Travellers are not always aware of the risk when venturing to another country.

		You can watch Sanofi’s campaign videos 

. They are straightforward and to the point, almost acting as a mini documentary or news report about the dangers of counterfeit medicines. In addition, the videos show how Sanofi is working to prevent counterfeit medicines. The company is also rolling out a passport, which provides information to travellers about how to protect themselves and how to spot suspicious medicines abroad.

		Sanofi is not the first Big Pharma company seeking to educate patients about counterfeit medicines. In 2009, Pfizer launched a similar public campaign. Unlike Sanofi, however, Pfizer used a more heavy-hitting approach, including an advert shown in cinemas of a man coughing up a dead rat (some counterfeit medicines have been found to contain rat poison). The advert was designed to shock, but also elicited a large number of complaints, although the UK’s advertising watchdog later ruled that the advert had not breached any advertising standards. The advert was complemented by a 

 containing detailed information about the dangers of counterfeit medicine and buying medicines online.

		Campaigns such as the above show how the role of the pharmaceutical industry is changing. Not only are companies still expected to research, develop and manufacture innovative medicines, there is also a growing expectation for companies to deliver even more value to patients, such as by raising health and disease awareness.

, we take a close look at how manufacturers are seeking to better protect their supply chains against counterfeit medicines.

Sanofi Campaign Targets Counterfeit Medicines

The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring. A 

 has been launched for stakeholders to comment on the phasing-in of requirements for such a symbol. The black symbol would be placed in the product information along with the statement: “This medicinal product is subject to additional monitoring”. 

Among other points, the EC is interested in hearing about the practicalities of adapting existing product information to the new requirements, particularly the time needed for companies to make the necessary amends. The symbol will need to be applied to all currently marketed products that fall within the scope of the additional monitoring requirements. As such, companies will have to adapt their packaging leaflets, which will be subject to a regulatory procedure by means of a variation.  

Additional monitoring is an important part of Europe’s new pharmacovigilance legislation and the symbol will be an important communication and awareness-rising tool. The EC wants to make healthcare professionals and patients aware of products that are subject to additional monitoring to initiate more targeted supervision of such products and to encourage the reporting of any specific, related observations. 

All comments must be received by Jan. 10, 2013. 

The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring.

Europe Considers Black Box Warnings

A golden era of productivity awaits the pharmaceutical industry in 2020, according to a report from PricewaterhouseCoopers (PwC). In an industry that seems to be dominated by headlines of job cuts and low growth, it’s a relief to hear positive news that suggests there’s light at the end of the tunnel.

		With all the bad news we hear in the pharma industry, such as drugs going off patent and companies cutting back on R&D, it’s easy to overlook the advances that are being made. In particular, the 

, explains that there have been huge leaps forward in areas such as genetics and genomics, processing power and data management tools, which gives pharma companies the ability to collect and make use of biological data in R&D.

		“Every patient experience now generates rivers of data which, if pooled intelligently, can trace a detailed portrait of a patient’s health and, when aggregated with other patient data streams, can coalesce into deep reservoirs of knowledge about entire disease states and patient populations,” says an industry marketer in the report.

		Even today, we’re already seeing the effects of personalised medicine. For instance, genetics have led to greater understanding of breast cancer. For years, scientists believed that breast cancer was a single disease, but now ten subtypes, each with a unique genetic fingerprint, have been identified. Improved understanding of the disease has produced new diagnostics and R&D approaches.

		The genomic research firm CardioDX has also made advances in the area of coronary artery disease. The company analysed more than 100 million gene samples to identify primary predictive genes for the disease and has developed a test that can identify it in its earliest stages.

		Even the complex field of Alzhemer’s disease is finally starting to see progress. Earlier this year, Pfizer’s and J&J’s Alzheimer’s drug bapineuzumab was in the headlines after the highly publicised failure of a key clinical trial. However,

 also suggested that the drug did show some signs of working, but perhaps only in an earlier stage of the disease.

		Progress has also been made in other fields; for example, stem-cell therapies and gene therapies are now reaching the market. Work in epigenetics has also led to greater understanding about heritable biological elements that aren’t directly encoded into DNA. Researchers are now creating wiring diagrams of cells whose breakdown causes a particular disease. Ultimately, the work could help pharmaceutical companies to develop treatments that fix the underlying components of a disease.

		Overall, the PwC report forecasts that the global pharmaceutical market could be worth nearly $1.6 trillion by 2020.

		There’s still a lot to learn about the human body, but it’s important to acknowledge how far we’ve come. By 2020, we will, perhaps, start to see the rewards of the financial and intellectual investments that have been made. What developments do you think we’ll see?
		Just to demonstrate how quickly advances in the scientific world can occur, I’ll leave you with this fact from the PwC report. In 2001, it cost $95 million to read an entire human genome. Today, manufacturers are developing machines that can do the same for just $1000 in a matter of hours.

A golden era of productivity awaits the pharmaceutical industry in 2020, according to a report from PricewaterhouseCoopers (PwC).

Personalised Medicine: Pharma’s Golden Era?

More favourable conditions for the pharmaceutical industry, including a “golden era of renewed productivity and prosperity” have been forecast in a new report from analyst firm PricewaterhouseCoopers (PwC). According to the report, major scientific and technological advances, coupled with sociodemographic changes, increasing demand for medicines and trade liberalism, will help to transform the industry’s fortunes in 2020. 

The report explains that there are three major challenges facing the industry at the moment: rising customer expectations, poor scientific productivity, and prevailing management culture, mental models and strategies that companies still rely on. 

In addition, the report explains that there is a need to alter the concept of healthcare. Several industry trends have converged to increase the costs of healthcare and a proposed model is to focus on curing or preventing disease rather than treating it.

Several steps are described that pharmaceutical companies can take to ensure they make it through the challenges ahead and survive until 2020:

Provide real-world data on medicines’ outcomes. Pooling data can provide vast knowledge about disease states and patient populations.

Decide how much to invest in growth markets. The biggest markets may not be the most profitable ones. In addition, the costs of setting up local manufacturing may outweigh additional custom.

Consider the implications of investing in new treatment types, such as vaccines and regenerative medicines. Be selective about the diseases approached. 

Invest more heavily in genetics and genomics, and revise R&D processes. Knowledge of genetics and genomics can lead to more effective personalised medicines. 

Collaborate with academia, government and nongovernment organisations, and other companies to access the best science and expertise.

Companies need to focus on innovation that addresses the needs of patients, payers and providers.

The report, From Vision to Decision Pharma 2020, can be downloaded for free from PricewaterhouseCoopers 

More favourable conditions for the pharmaceutical industry, including a "golden era of renewed productivity and prosperity" have been forecast in a new report from analyst firm PricewaterhouseCoopers (PwC).

A Golden Era for Pharma in 2020

The European Fine Chemicals Group (EFCG) has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the EU market. EFCG believes that such inspections will help to harmonize the global rules and regulations concerning APIs and pharmaceutical products.

The group proposes that inspections be conducted using a Mutual Recognition Agreement (MRA) approach involving national regulatory authorities sharing inspection resources. An EFCG position paper estimates that the cost of inspections will be approximately EUR 2.6 million ($3.3 million) over a three-year period and suggests that financial resources could come from participating companies wishing to sell their APIs in the EU marketplace.   

During the past decade, the market for generic APIs has increased and a greater number of APIs used in European medicines are sourced from China and India. API manufacturers in these countries, however, are rarely inspected by EU authorities. In a position paper, EFCG claims that 70% of all APIs consumed in Europe are imported from China and India. With the vast majority of manufacturers unregulated, some APIs may contain impurities or may be in breach of EU quality standards. Cases cited by the position paper include glycerine contaminated with antifreeze (2006), heparin contaminated with chondroitin sulphate (2008) and contaminated cardiovascular drugs in Pakistan (2012).

Assuming 860 API manufacturing sites were inspected once every three years by 33 inspection authorities (EU (27), USA, Australia, Japan, Switzerland, new Zealand, Canada) to the same standard (ICH Q7) and that they are willing and able to share the inspection outcomes, then around 8 sites need to be inspected each year by each inspection authority, states the position paper. 

EFCG has been calling for mandatory inspections of all global API sites since 2004.

The European Fine Chemicals Group has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the European Union market.