ACTA, Democracy & Access to Medicines

See ACTA text here

Briefing Note for Members of the European Parliament by HAI, TACD, MSF and Oxfam

PDF version here

Negotiations are not the end of the road - ACTA is a blank cheque for the future

In a move that would circumvent open debate and due scrutiny, the agreement proposes an annual meeting of signatories where amendments to the Treaty can be negotiated. Even some of the most contentious issues that have been removed during the negotiations could, within a year, be back in the text once ACTA is out of the public spotlight. Any future changes to ACTA must be subject to public scrutiny by all stakeholders and must receive parliamentary approval. (ACTA, Art. 6.4: Amendments, Arts. 5.1.2. 5.1.4)

Changing EU foreign policy through the back door: Circumventing WIPO and WTO

International agreements on intellectual property fall under the purview of the World Trade Organisation (WTO) and World Intellectual Property Organisation (WIPO). The EU has, together with the other ACTA negotiating parties, bypassed these multilateral institutions. ACTA is designed and intended to be expanded and become a global standard. Once ACTA is established, we are likely to see a push to expand the number of signatory states. ACTA effectively will establish a new institution where European Parliament scrutiny is absent and where stakeholders, such as civil society, are not represented as they are in these multilateral institutions. This is a regressive step with regards to EU democratic processes and multi stakeholder involvement.

The ACTA process constitutes an explicit de facto EU foreign policy choice which has far reaching implications for EU foreign policy. These EU foreign policy repercussions of ACTA have not been debated nor considered by the European Parliament, especially with reference to developing countries should be evaluated, studied and publicly debated.

ACTA will hurt Access to Medicines: remove patents from scope of the agreement

Generic competition is key for bringing down prices and ensuring access to affordable medicines around the world. The disproportionate enforcement measures proposed in ACTA: damages, injunctions and other remedies, will inhibit generic competition through excessive persecution of possible IPR violations, strengthen monopolies on medicines and enhance the rights of brand pharmaceutical companies at the expense of access for the poorest citizens. ACTA’s IPR enforcement measures would be a strong barrier against price-reducing generic competition and would jeopardise the free flow of legitimate medicines across borders.

The name Anti Counterfeiting Trade Agreement does not accurately represent the contents of the agreement. ACTA would be better referred to as an ‘Intellectual Property Enforcement Treaty’ as it encompasses many categories of intellectual property rights. ACTA does not only affect counterfeiting, which relates to trademark law, but also patents, copyright, data protection, geographical indications, integrated circuit protections, trade secrets, and other laws. Counterfeiting is related to wilful and commercial scale trade mark infringement only. Raising patent protection will not protect patients but hurt them.

The scope of the agreement overreaches and is too broad: the agreement should be limited to commercial scale counterfeiting and piracy. Most importantly, patents and civil trademark infringement should be removed. (ACTA, p6. Article 1.X: Definitions)

Patents

Including patents in ACTA will without question hamper generic trade, innovation and access to medicines. As the equivalents of existing brand medicines, generics are closely linked to patent law, and can only enter the market when there is no patent or when the patent has expired. The level of protection for patents has already been established under the TRIPS Agreement, and there was an effort to balance IPR rights with the right to access to medicines. Advancing patent protection further by means of excessive enforcement provisions will undermine the balance found in TRIPS.

The EU negotiators have been pushing to include patents in ACTA whilst the US and other parties have included a footnote in brackets that excludes patents. To protect access to affordable medicines, patents must be excluded from the agreement. (ACTA, Ch II.Sect. 2: Civil Enforcement)

Damages, injunctions and other remedies: A chill on innovation and competition

The current wording on damages in the text could allow for excessive damages for infringement that go beyond current standards, and which could have a strong dissuasive effect on generic competition. By increasing the damages to this extent the agreement effectively expands the rights of the IP right-holder, increasing the risks and decreasing the viability for competitors seeking to enter the market. This will dampen innovation and the production and trade of generic medicines.

The proposed high levels for damages and penalties will affect the laws in some EU Member States. Damages based on suggested retail price go beyond the acquis. Regarding destruction of infringing goods and production facilities, the acquis has more checks and balances than ACTA. Injunctions against a third party are more limited in the acquis than under ACTA, the acquis also has broader exceptions. (ACTA. Ch II.Sect.2. Art. 2.2)

ACTA puts third parties—such as distributors and even non-governmental organisations or public health authorities—at risk of severe penalties

Third parties are at risk of injunctions, provisional measures, and even criminal penalties, including imprisonment and severe economic losses. All of these are TRIPS-plus and with potentially far-reaching consequences. This could implicate, for example, suppliers of active pharmaceutical ingredients used for producing generic medicines; distributors and retailers who stock generic medicines; NGOs who provide treatment; funders who support health programs; and drug regulatory authorities who examine medicines. This could act as a significant deterrent to anyone involved in the production, sale and distribution of affordable generic medicines. (ACTA Ch. II, Sect. 4, Arts. 2. 14.4, 2.15, 2.16.)

ACTA undermines due process and judicial guarantees

ACTA undermines the judiciary by allowing extra-legal processes: it would limit access to due process for IP challenges by permitting the seizure and destruction of medicines without notification of the owner, providing the owner with the opportunity to respond, or mandating judicial oversight. Such ex parte measures are susceptible to abuse. Even where judicial process is mentioned, the balance lies heavily in favour of the rights-holder alleging infringement. Under ACTA there is limited power to balance health issues against the interests of private companies. The cooperation of IPR rights holders proposed in ACTA with authorities should be balanced by fair, legal hearings with the participation of the parties accused of the violation. (ACTA Ch. II, Sec. 3, Art. 2.11.1.)

Inclusion of Civil Trademark infringement: A problem for Access to Medicines

ACTA could still constitute barriers to medicines going to developing countries

Civil trademark disputes on similar labelling do not pose threat to public health. Yet far reaching enforcement can pose threat to access to medicines.

ACTA could increase border searches and interfere with the transit of legitimate medicines. The border measures section no longer includes patents yet still includes civil trademark infringement with increased penalties. This means a customs official could initiate a seizure and even destruction of an allegedly infringing good without judicial review or even notification to the rights holder—on the basis of an assertion of a commercial trademark dispute. This is illustrated by the German detention case for alleged trademark infringement(regarding Amoxicilin). The scope should be limited to wilful commercial scale trademark infringement where fraudulent exact copying of the labelling and branding is the case.. (Compare ACTA Ch. II, Sec. 3 with TRIPS Ch. III, Sec. 4, Art. 59., ACTA Ch. II, Sec. 3, Art. 2.X: Scope of the Border Measures)

If ACTA is finalized, the following significant changes would be necessary:

• ACTA should only be applicable to wilful copyright infringement on a commercial scale. It should exclude both patents and civil trademark infringement from the scope of the agreement.

• No action should be taken by authorities without due process and full judicial review with the participation of the alleged infringer.

• Protections against abuse must exist, including access to information for the alleged infringer, and the obligation to consider proportionality and the public interest in setting the remedy.

• ACTA should not mandate excessive punishment for alleged civil infringement. Civil and criminal enforcement should not be TRIPS-plus or nor require a change in a state’s laws or the acquis.

• ACTA should not establish third party liability nor penalties for "aiding and abetting".

• Any institutional structure established should be open and transparent. It should not have the authority to amend ACTA without public scrutiny and approval from democratic bodies, such as the European Parliament.

• The EU should commit to refraining from proposing the ACTA agreement as a requisite for EU- Third-party free trade agreements.

Selling Sickness through unbranded disease awareness campaigns?

European legislation prohibits advertising of products that have prescription-only status, as well as stating that advertising of medicinal products, when it is allowed, should neither be misleading nor inconsistent with the summary of product characteristics.

Key relevant underlying principles within the European legislation and the WHO Ethical Criteria for Medicinal Drug Promotion include avoidance of activities that take undue advantage of people’s concerns for their own health, and promotion disguised as scientific or educational activities.

In this presentation (download), Teresa Alves has used illustrative case studies to explore the nature and content of the information provided by pharmaceutical companies about medical conditions and their diagnosis and treatment. Cases include a range of situations including chronic disease treatments, controversial expensive new drugs, disease prevention strategies, and lifestyle conditions.

The analysis of case studies brings up questions concerning the public health implications of the information that is provided by companies, as well as the potential risks and benefits for citizens. Are companies providing useful information or expanding markets to sell their products?

HAI Europe Statement: EMA talks the ‘conflicts of interest’ talk, but will it walk the walk?

18 October 2010 – The European Medicines Agency (EMA) has taken a step in the right direction by adopting an improved policy to handle potential conflicts of interest among its scientific committee members and experts. Independence in scientific and expert advice is crucial to balanced decision making. Conflicts of interest (CoI) can bias regulatory affairs, and compromised decisions could result in the market approval of medicines of questionable efficacy or unproven safety, which would ultimately put citizens at risk.

The Agency has re-iterated its commitment to transparency by pledging to publish all committee members’ and experts’ declarations of interest online. The EMA will also ‘pro-actively’ screen all declarations of interest prior to the individual’s formal nomination by the competent authorities. These standards can only be effective if the Agency takes the responsibility for their enforcement and compliance. HAI Europe encourages the EMA not only to pro-actively screen the declarations, but also to verify their accuracy. Experts’ participation in EMA activities should be conditional on the complete and public disclosure of any potential conflicts of interest.

Furthermore, the new policy still raises some unanswered questions:

• Given the number of exemptions made for ‘expert witnesses’, how can the impartiality of this advisory position be ensured?
• Deadlines for interest disclosure and implications for failing to uphold or adhere to this policy were curiously absent from the Agency’s statement. The policy could easily flounder if the EMA does not commit to continuous monitoring of its application and to establishing clear consequences for non-compliance.
• As this improved policy to handle conflicts of interest has been said to apply only to the scientific committees, will the Agency also be revisiting and issuing a CoI policy vis-à-vis the Management Board?
• Participation in the Patient and Consumers’ Working Party (PCWP) and in the Healthcare Professionals’ Organisations Working Group is governed by different criteria. Will the agency be reassessing criteria soon, based on recent reports on CoI and corporate sponsorship at PCWP level?

HAI Europe maintains that the Agency’s financial and intellectual independence from the pharmaceutical industry remains an essential component of sound regulatory decision making. The EMA’s improved policy on conflicts of interests could strengthen independent scientific and expert advice, provided that the policy is properly implemented and monitored. It’s a case of wait and see.

Report: Public information as a medicines marketing tool

A recent report from Healthy Scepticism / Gezonde Scepsis describes ways in which pharmaceutical companies provide the public with information about diseases and conditions. It provides an overview of the various methods used, and the impact that public information campaigns can have.

The aim of this report is to demonstrate how companies use public information campaigns about diseases and conditions as tools to market their medicines. In the research, the authors Sandra Nuland and Zamire Damen have carried out three case studies to demonstrate how various methods are applied and the parties are involved.

Read the report Public Information as a Marketing Tool

Systematic review of drug promotion's influence on prescribing

An important new systematic review on the content and effects of drug promotion is just out in PloS Medicine, featuring HAI Europe members Joel Lexchin and Peter Mansfield as co-authors.

Read the article Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review

Doha Declaration Par 6 to be reviewed in TRIPS Council

On the 27th of October WTO members will discuss the 'health waiver' of Paragraph 6 in the Doha Declaration which allows countries to issue a compulsory license for export, enabling access to medicines in countries without sufficient manufacturing capacity.

So far this mechanism has only been used once, and has proven to be very problematic and by some deemed as unworkable.

After much resistance by some developed countries to adress the issue, now an entire day will be devoted during the TRIPS Council to reviewing this mechanism. Why has it not been used more often? And can the mechanism be improved? , are questions that deserve to be posed and need to be answered as the problem of access to medicines has most definitely not been solved.

See IP watch article for more information

Welfare Implications of Intellectual Property Enforcement

HAI staff contributed to a paper on the Welfare Implicationns of Intellectual Property Enforcement which was published in the PIJIP Research Series at the American University in Washington DC, available at : http://digitalcommons.wcl.american.edu/research/.

Abstract

The enforcement of intellectual property rights is often presented as a neutral legal phenomenon aimed at ensuring compliance, or giving effect or force to a law. Enforcement of intellectual property rights has gained increasing international attention and legal strength. More and more, existing international substantive standards are being supplemented with secondary norms, which in principle deal with the fulfillment of the former. However, the value placed on these secondary norms and intellectual property enforcement initiatives contrasts with little knowledge or understanding of their implications for resources and overall welfare. Moreover, the aforementioned neutrality recedes when it becomes apparent that some of the enforcement provisions contained in treaties, in fact, constitute a substantive expansion of rights instead of merely adding secondary norms of adjudication. This trend requires a much better understanding of what enforcement signifies and what the costs of implementing international intellectual property commitments may be, taking account of its effect on the economy and on society as a whole. This understanding may be particularly important when a lack of ownership of the agreements setting up new enforcement obligations exists, namely, when some of the parties are pursuing goals distinct from those mentioned in the text of the agreement.

A useful analytic tool with regard to the definition of enforcement can be found in the distinction between primary and secondary norms, with enforcement norms falling into the category of secondary norms of adjudication. Additionally, when considering the resource implications of enforcement, it is import to distinguish between the costs of enforcement and the welfare effects of enforcement. The costs of enforcement represent the investment a country makes in order to adequately comply with the commitments it has made, whilst the welfare effects denote the impact of new enforcement measures, assessed using variables that stem from the initial economic variables affected (i.e. production, exports, imports, investment). These changes in turn affect consumption and access to public goods, expenditure and welfare.

This conceptual framework leads first to seek to identify the costs of adequately complying with a treaty, and second to devise a methodology that allows, in a case-specific manner, to identify the impact or effects of enforcement measures on the economy and on society as a whole.

Seuba, Xavier, Joan Rovira, and Sophie Bloemen. 2010. Welfare Implications of Intellectual Property Enforcement Measures. PIJIP Research Paper no. 5. American University Washington College of Law, Washington, DC.