The EU's Directorate General for Tax and Customs Union (DG TAXUD) published a report in July 2009 which showed that European customs authorities had detained 126% more goods suspected of infringing IP rights in 2008 than in 2007. This was a rise from 79 million to 178 million articles.

This was replicated in the pharmaceutical sector, with the report demonstrating a 57% increase in the volume of counterfeit and patent-infringing medicines seized. The report identified India as the main source of infringing medicines, followed by Syria, the United Arab Emirates and the Ukraine. The statistics presented in DG TAXUD's report take into account the 2008 EU-wide Medifake action, where customs authorities targeted illegal medicines entering the EU, stopping over 32 million medicinal products.

EU statistics are consistent with global trends. The WHO estimates that counterfeit pharmaceuticals represent over 30% of pharmaceuticals in some developing countries. In many of the former Soviet Union countries, for example, the rate of counterfeit pharmaceuticals is estimated to exceed 20%. Counterfeit medicines can also be found in markets that are looked to for best practice policies; for example:

In the past, counterfeiters restricted their activities to expensive anti-cancer medicines or lifestyle drugs such as Viagra. DG TAXUD's report demonstrated that counterfeiters are now targeting a far wider variety of medicines, however, ranging from:

The internet provides convenience and savings to patients who choose to purchase medicines from legitimate online pharmacies. However, the wide reach and anonymity that it provides have made it possible for counterfeiters and others dealing in illegitimate medicines to reach a global audience quickly, cheaply and with relative impunity. Consumers are often confused as to which offerings are legitimate and which are not.

The World Health Organisation (WHO) estimates that over 50% of medicines purchased over the internet from sites that conceal their physical address are counterfeit. Research by the Royal Pharmaceutical Society of Great Britain (RPSGB) reveals that 2.25 million people buy prescription medicines online; one-third of these medicines are estimated to be counterfeit. Almost 60% of spam sent via the internet relates to medicines. A recent study by the European Alliance for Access to Safe Medicines (EEASM) found that:

The particular problems that the internet and new technologies pose have led to a variety of initiatives (see below, Initiatives concerning the internet).

In April 2007, a group of countries began negotiations on ACTA. The US trade negotiators stated that it will represent "a new, state-of-the art agreement to combat counterfeiting and piracy".

The negotiations now include:

Documentation published by the negotiating parties and stakeholders consultation meeting confirm that ACTA will focus on enforcement measures and not address:

However, ACTA will include mechanisms that pharmaceutical companies can rely on to tackle pharmaceutical crime, particularly in markets whose legal regimes may not be as robust as those in the US or EU. Provisions under discussion include:

Negotiations will continue in Mexico in January 2010. The negotiating parties intend to conclude the agreement as soon as possible in 2010. However, given that the initial target was to finalise the agreement in 2008, it remains to be seen whether the 2010 deadline will be achieved.

The Council of Europe (COE) brings together 47 countries with the aim of developing common principles based primarily on the European Convention on Human Rights. The COE has been working, since 2006, on a proposal for an international agreement to facilitate co-operation among its member states in combating pharmaceutical crime.

In February 2009, a COE-organised group of specialists on counterfeit pharmaceutical products published a first draft, entitled the Draft Convention of the Council of Europe on counterfeiting medical products and similar crimes involving threats to public health (Draft Convention).

As currently drafted, the Draft Convention seeks to tackle pharmaceutical crime in general, not just counterfeit pharmaceuticals. It applies to:

The Draft Convention seeks to prevent and combat threats to public health by:

It also provides for a dedicated monitoring mechanism to ensure the Convention is implemented in an effective manner.

The Draft Convention criminalises the following acts, if committed intentionally:

The Draft Convention also renders it a criminal offence to intentionally possess a counterfeit medical product or related documents for the purpose of committing any of the above offences. In addition, it requires member states to establish corporate liability (civil, criminal or administrative) for these offences. They have discretion whether to criminalise attempts to commit these offences.

Member states must introduce measures to ensure that criminal and/or other sanctions are applied to those manufacturing or supplying non-counterfeit medical products that have not been authorised by or are in breach of their rules.

Any criminal sanctions that the member states introduce should:

The Draft Convention also requires member states to provide for the:

The Draft Convention requires member states to introduce other measures to promote enforcement, including to:

The European Committee on Crime Problems (CDPC) adopted the Convention on 16 October 2009. The text will now be considered by the Parliamentary Assembly and the Committee of Ministers. An established Convention text is expected to be ready for signature by February 2010. Five signatories are necessary, including three COE member states, for the Convention to enter into force. The Convention will then bind the states that proceed to ratify the agreement.

The COE is also working with the IMPACT group to review the responsibilities of stakeholders in the distribution chain, such as ISPs and other service providers (see below, IMPACT).

In 2006, the WHO established IMPACT to mobilise awareness in the fight against fake medicines. All 193 WHO member states participate in IMPACT on a voluntary basis. IMPACT brings together:

IMPACT's five key areas of focus are:

A hotly debated topic (inside and outside the WHO) has been the revised definition of a "counterfeit medical product". Currently, the WHO definition is confined to medicines "deliberately and fraudulently mislabelled with respect to identity and/or source…". As an initial step, the IMPACT group has sought to improve and expand the WHO's definition to capture all medical products (not just medicines).

The IMPACT Group's proposed revised definition is as follows:

The definition also makes express what is not covered by the definition of counterfeit medical products:

The revised definition, like the existing definition, makes clear that the primary characteristic of counterfeiting is consumer deception as to "identity and/or source". This deception can (and often does) occur even in the absence of a trade mark infringement (although these infringements remain an important subset of counterfeit medical products because their essence is consumer deception).

IMPACT has achieved substantial consensus around the revised definition. However, it has encountered opposition from Brazil, India and other developing countries. They fear that it could be used to limit parallel trade and access to generic medicines. This is despite the explicit disclaimers in the definition's explanatory text to the contrary. In addition, given the WHO's current focus on the swine flu pandemic, further consideration has been delayed until at least 2010. IMPACT is also discussing other definitions including those that identify the:

IMPACT plans future initiatives covering:

IMPACT is also working to prepare a guidance to combat internet trade of counterfeit medical products (see below, Initiatives concerning the internet: IMPACT's internet guidance).

The Proposed Falsified Medicines Directive (which forms part of three proposals introduced in the Commission's update of the "Pharmaceutical Package" adopted in December 2008) seeks to amend existing EC legislation aimed at preventing the entry into the legal supply chain of falsified medicinal products destined for human use. It proposes a harmonised European response to deal with pharmaceutical crime and the severe threat it poses to public health.

The key changes include:

The Parliament, Council and industry stakeholders have called for three further elements to be added to strengthen the Commission's proposal:

Before implementation of the Directive into national law, the Parliament and Council will first review the Commission's proposal under the co-decision procedure. The new legislation is expected to come into force in the second half of 2010.

In March 2009, the Council of the EU adopted a resolution endorsing the Customs Action Plan, intended to combat infringements of IP rights. It identifies four main counterfeiting challenges:

DG TAXUD and the member states will implement the Customs Action Plan. It contains the following initiatives:

The Commission's review of the Border Control Regulation and relevant implementing provisions is aimed at clarifying and harmonising the application of the customs rules across the member states. To this end, DG TAXUD is currently undertaking an internal review that will result in a proposal to be submitted to the Council.

There is no fixed timetable for the review and no formal public consultation is planned. However, DG TAXUD has asked relevant stakeholders to provide input and welcomes ideas from those with whom it has not already informally consulted. On completion of the review, a proposal to modify EC customs legislation in accordance with the findings will be submitted to the Council.

The issues DG TAXUD is considering include:

The IP Rights Enforcement Directive harmonises the rules for the civil enforcement of IP rights across the EU, including provisions relating to:

Member states had to submit a report on the Directive's implementation to the Commission by April 2009. DG MARKT is currently drawing up a report on the effectiveness of measures taken by member states to be shared with the Parliament and Council. If necessary, it will follow this report with proposals to amend the Directive itself.

Due to the late implementation of the Directive by a number of member states, however, the Commission is still awaiting receipt of some national reports. DG MARKT expects to complete its implementation report in the first quarter of 2010, followed by a second report evaluating of the Directive's impact on innovation and the development of the information society in 2011. On the basis of these reports, the Commission will then decide whether or not to propose amendments to the Directive.

While the civil enforcement rules are harmonised in the EU, the criminal rules are defined at national level. To address this gap, in 2005, DG JLS adopted proposals to supplement the Directive with harmonised criminal rules concerning IP infringement. This includes:

Many stakeholders (particularly the member states) have criticised the proposals, questioning the Commission's competence to initiate legislation concerning criminal enforcement. At the end of 2005, the ECJ passed judgment in Commission v Council (Case C-176/03). The ECJ stated that the Commission can propose legislation requiring the criminalisation of certain acts, but cannot establish criminal penalties in any degree of detail. The controversy surrounding the Commission's proposal later led to its withdrawal.

The Commission has recently indicated that it will revive the draft legislation. If it does, it could provide pharmaceutical manufacturers with an opportunity to enhance the tools available EU-wide to tackle pharmaceutical counterfeiting.

These include:

This is intended to combat the internet trade of counterfeit medical products, specifically:

The group also plans to develop consumer education campaigns to warn consumers of the potential risks of buying medical products online. A draft text is due to be circulated for comment.

Some pharmaceutical societies have launched online logo schemes to aid patients in verifying the legitimacy of online pharmacies. For example, the RPSGB has introduced a logo which is displayed on the front page of participating online pharmacy sites. It allows patients to identify whether a website offering to sell medicines or provide other pharmacy services is connected to a registered pharmacy. Each logo includes a pharmacy premises registration number, which is unique to that pharmacy. By clicking on the logo visitors are linked to a page on the RPSGB website where they can verify that the site of their intended purchase is that of a registered pharmacy. If a pharmacy is registered with the RPSGB, a patient knows that the pharmacists and technicians should comply with the high standards of conduct, practice and performance laid down in the RPSGB's code of ethics, including the professional responsibilities set out for those involved in the sale and supply of medicines via the internet.

VIPPS is an information and verification site operated by the National Association of Boards of Pharmacy. Similarly to the UK system, before being permitted to display the VIPPS hyperlink system, the pharmacy must comply with the licensing and survey requirements of:

In addition, pharmacies displaying the VIPPS seal have demonstrated compliance with criteria that can reassure patients in making online purchases, including:

The UK's MHRA is also taking steps to tackle online distribution of counterfeit medicines. Among other things, the MHRA employs specialist internet investigators to monitor products that are on the MHRA's "watch list" and take action as appropriate. This is part of a broader, formal MHRA anti-counterfeiting strategy, which encompasses:

The MHRA is currently updating this strategy.

Through its "Internet Days of Action" programme, the MHRA has showcased its online enforcement activities to other European medicines agencies to raise awareness of the increased risk of obtaining substandard medicines from unlicensed websites.

Members of the European Parliament have identified the internet as the main point of entry for counterfeit medicines into the EU's legal supply chain and have formally asked the Commission how it will protect Europe's consumers. Among other things, MEPs have proposed certifying internet websites as a way of hindering illegal internet trade.

The Commission considers that its opportunities for preventive action are limited by divergent national rules governing the distance-sale of prescription medicines; some member states have chosen to prohibit such sales while others permit sales under differing conditions. The Commission has, therefore, taken the view that this is a task for member states and points to actions taken at a national level including in Germany and the UK (see above).