Fake medicines… genuine solutions?

A debate about how to fight counterfeit medicines in Europe.

The number of counterfeit medicines detected in the European Union has increased sharply in the past few years. These fake pills and treatments pose a risk both to patient safety and the pharmaceutical industry. European Voice invited five experts to discuss the issue and to debate the draft EU directive intended to stem the flow of counterfeit products.

All the panellists agreed that there were no easy answers and that the directive would not solve the entire problem. Much time was spent discussing sales of fake medicine on the internet, which is not included under current proposals. But there was no consensus about whether the internet should be included in the EU law or not.

Marisa Matias, a Portuguese left-wing (GUE/NGL) MEP who is drafting the European Parliament’s position on the counterfeit medicines draft directive, said she hoped to fill in the gaps in the European Commission’s proposal. One crucial issue for her is to extend the legal base. She also wants to clarify the roles of all the people in the supply chain and examine how the EU can address problems around the transparency and quality of sales on the internet. She would also like to include amendments to ensure that customs inspectors have adequate training and look at how regulators can make their work easier.

Stuart Hurst at Eli Lilly explained why counterfeit medicines are so damaging for the pharmaceutical industry. On average, it costs the industry $1 billion to bring a new medicine to the market, allowing counterfeiters to cash in on successful products. Although it is often assumed that counterfeiters are only interested in lifestyle drugs, this is not the case, Hurst said. For instance, Eli Lilly has seen some very sophisticated copies of its schizophrenia treatment, Zyprexa. He said that he welcomed the Commission’s proposal, but wanted to keep the focus on stopping counterfeit medicines from getting into the legitimate supply chain, rather than illegal internet sales.

Thony Björk of the Pharmaceutical Group of the European Union said that urgent action was needed to tackle the problem. “At stake is patient confidence in medicines,” he said. Speaking for an organisation representing pharmacists in 30 European countries, Björk said that pharmacists welcomed new developments in safety features on packaging that made medicines harder to counterfeit. But he stressed that “a balance must be struck between an effective system and an affordable system”. Policymakers need to avoid “an unnecessary increase in the price of medicines” as a result of new safety features. he said.

Monique Goyens of the European Consumers’ Association (BEUC) echoed these concerns: any measures to combat counterfeiting would have “huge costs”, which she expects consumers will bear. Therefore cost-benefit analysis is required before making any decisions about safety features, she said. Goyens also stressed the importance of tackling internet sales and raising awareness of the risks of counterfeit medicines.

Danny Struys, an inspector with the Belgian customs authorities, spoke about his experience of EU law on the ground. “It is not a pleasure,” he said. “The legislation is absolutely not adapted to reality.” He estimates that customs authorities at Brussels Airport, where he works, are picking up less than half the counterfeit medicines passing through the airport.

Last year European customs officials succeeded in stopping 34 million fake pills from getting into the supply chain during a two-month, pan-European operation. But no big gains have been made since.

Fact File

The panel

Marisa Matias, Portuguese member of the European Parliament in the European United Left/Nordic Green Left (GUE /NGL) group, rapporteur on the Commission proposal.

Stuart Hurst, director of European government and public affairs for Eli Lilly.

Thony Björk, president of the Pharmaceutical Group of the European Union.

Monique Goyens, director-general of the European Consumers Organisation (BEUC).

Danny Struys, an inspector with the Belgian customs authorities at Brussels Airport.

Moderator: Peter O’Donnell, assistant editor, European Voice.

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“The key to the problem is that there are not enough customs officers,” said Struys. “Please, please give us more staff and we will stop much more.” He finds that officials are being asked to take on more tasks, but have less time. He also pointed out that training needed to be improved in some countries, noting that two EU member states made no seizures last year.

What is the problem?

In her opening remarks, Goyens described the mystery shopping exercises that BEUC researchers carry out. The medicines they bought over the internet had “major quality problems “with missing active ingredients, contaminated ingredients, no safety information or patient information leaflet.

The panel came up with several reasons why counterfeit medicines are such big business. High profits are the obvious reason, singled out by most of the panellists. But also, said Hurst, the chances of counterfeiters being caught are low and punishments minimal: “There is a lot of money being made for very little risk,” he said.

Struys also pointed out that four-fifths of the world’s population do not have access to medicines, which created demand in the developing world. Struys said a big incentive to produce counterfeit medicines is that the price of medicines is “too high”, which to him suggested overhauling the patent system – a proposal rejected by other panellists.

The counterfeit problem in Europe may be less widespread than in developing countries, suggested Goyens, but it was a genuine problem and reflected consumers’ lack of information about the risks. If consumers were fully aware of the risks, they would not buy counterfeit medicines, she said.

Speaking from the audience, Severina Scarnecchia of the European Chemical Industry Council (CEFIC) emphasised the importance of precise legal definitions: “You counterfeit a brand but you falsify everything. They are different from a legal point of view.”

The legal base

The Commission’s proposal is drafted under the internal-market rules of the EU’s rule book (article 95 of the Nice treaty). But Matias vowed to fight for a double legal base, so that the law is also under article 152 (protection of public health). Peter O’Donnell, the moderator of the event, challenged her to explain whether this would have any real impact. She replied that the political signal would amount to a major difference: “This [directive] is more of a public health and patient safety issue than only an internal market issue.”

Matias said that people had a false idea that drafting legislation under an internal market legal base was always simple, while a public health legal base was complex.

All the panellists agreed that there needed to be a strong emphasis on patient safety. Goyens remarked that public health is one of the ways that “the EU can enter into people’s lives in a positive way” following the Lisbon treaty. She also proposed that medicines should be regulated by officials in the Commission’s health department rather than those from enterprise. Hurst at Eli Lilly also agreed that counterfeit medicines were a patient safety issue and said he was convinced by Matias’s arguments on the legal base.

The internet

Regulating counterfeit medicines bought and sold over the internet provoked some lively debate. Matias argued that ways to include internet sales in the directive should be found. Goyens said that policymakers had to take action on the internet, which is “a major strategic point”. She recommended an EU law to ensure that counterfeiters cannot advertise on internet search engines. Björk thought that regulating internet sales might be helpful, but would not solve the problem.

But Hurst was concerned that “getting stuck into the illegitimate supply chain” through the internet would be a distraction. He later clarified this by saying that he preferred a phased approach, with the immediate focus on stopping counterfeit medicines from getting into the legitimate supply chain.

Speaking from the audience, Peter Morgan, a member of the European Economic and Social Committee who drew up that institution’s report on counterfeit medicines, said that no one directive could solve this multi-faceted problem, especially in relation to internet sales. He argued for more draconian sanctions to stop the counterfeit trade, not simply fines.

Nigel Strang of the European Commission’s directorate-general for information society said that any proposal to ban internet sales failed to account for the ways in which the internet was changing and would change society. He painted a scenario in which doctors would send patients e-prescriptions, which could then be sent on to pharmacies, with patients checking the authenticity of their medicines with online bar-codes. 

Active ingredients

Severina Scarnecchia of Cefic asked whether there could be more inspections of third country manufacturers to check for fake active pharmaceutical ingredients (APIs). The moderator noted that the Commission has said it does not have the resources to inspect the thousands of API manufacturing sites beyond the EU.

Safety features

Hurst said that the industry is spending money on safety features, such as holograms and colour-shifting technology for medicines most at risk of being counterfeited. He described a pilot “coding and identification” project being tested by the European Federation of Pharmaceutical Industries and Associations (EFPIA) to verify medicines. The cost of the project, which is currently being piloted in Sweden, is €0.01-€0.03 per pack. Hurst said that the costs of safety features would fall on the industry. The end-user would not be affected because all prices would be negotiated by governments, he said.

O’Donnell asked whether these special features should apply to all drugs or just to prescription-only medicines. Hurst said that medicines at high risk of being counterfeited should have additional safety features. However, he had concerns about how high-risk medicines are defined. Goyens said special safety features should not just be for prescription medicines, but argued for a risk-based approach. She also countered the suggestion that counterfeiters were not interested in low-value medicines, noting that cheap products such as toothpaste were attractive for counterfeiters.

Morgan said that Europe had a chance to lead the world in developing these safety features as it did for mobile phone technology.

The supply chain

The moderator challenged all the panellists to explain how counterfeit medicines were getting into the legitimate supply chain. The panellists professed some uncertainty about how this happened. Matias said better sanctions and a better EU directive would help provide information about how these products get into the legal supply chain.

Struys argued that the supply chain was “too long and complicated with too many actors”. Banning delivery of medicines by courier would be one way to help get counterfeit medicines out of the system. Nobody mentioned the words “parallel trade”, but this may have been what some speakers had in mind. Matias was hesitant about cracking down on companies already in the supply chain. “These actors already exist. We don’t want to create unemployment, but we do need to clarify roles and responsibilities,” she said.

A questioner from the floor said that the pharmaceutical industry did not help themselves by “pushing medicines” on patients in “an aggressive way”. Hurst responded to this charge, noting that pharmaceutical companies were banned from direct advertising to consumers. He said: “The picture of us as pushing our medicine to individual consumers isn’t one that I am familiar with.”

Parliamentary timetable for legislation

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The Parliament’s environment, public health and food safety committee will debate counterfeit medicines on1 December, with a further exchange of views planned for February after Matias’s report is published (it is expected to go to the translators on around 8 December). The committee vote is planned for late February or early March. Matias would like a plenary vote in May and said that she intended to go for a first-reading agreement to the Council of Ministers.