Explanatory Memorandum to COM(2012)521 - Amendment of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the EC and third countries in drug precursors - Main contents
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| dossier | COM(2012)521 - Amendment of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the EC and third ... |
|---|---|
| source | COM(2012)521  |
| date | 27-09-2012 |
Drug precursors are chemical substances having a wide variety of licit uses, such as in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded for legitimate purposes on regional and global markets, but some of them can also be diverted from the licit distribution channels for the illicit manufacture of narcotic drugs.
Therefore, controlling drug precursors is a key component in the fight against narcotic drugs. Taking into account the wide legitimate uses of drug precursors, their trade cannot be prohibited. A specific regulatory framework, both at international and at EU level, has been put in place to monitor their legal trade and to identify suspicious transactions, thus preventing their diversion for illicit use.
Ephedrine and pseudoephedrine are chemical substances used for the manufacture of cold or allergy medicines. These two substances are also the main precursors for the manufacture of methamphetamine[1]. While ephedrine and pseudoephedrine are controlled at international and EU level, the medicinal products containing them are not controlled when they are exported from or transiting through the Union customs territory. They are therefore targeted by drug traffickers as a source of precursors for the illicit manufacture of methamphetamine because the ephedrine or pseudoephedrine contained in these products can be easily extracted (by using cheap home-made equipment and through a simple chemical process).
The fact that medicinal products for human use containing ephedrine or pseudoephedrine are excluded from the provisions of Regulation (EC) 111/2005, which applies to trade in drug precursors between the EU and third countries, has led to a situation where these products could not be stopped or seized by Member States' competent authorities when these products were exported from or transiting through the Union customs territory, even though it was very likely that they would be misused for the illicit manufacture of methamphetamine in their country of destination.
The EU is criticized internationally for not taking adequate control measures across Member States to tackle this weakness. Therefore, the EU is expected to close the loophole in the current legislation as regards the powers conferred to customs and police authorities who can stop and seize ephedrine and pseudoephedrine but cannot stop and seize medicinal products containing ephedrine or pseudoephedrine.
In its Conclusions of 25 May 2010, the Council invited the Commission to present a legislative proposal in this sense.
In 2009 almost 7400 seizures of methamphetamine, amounting to about 600 kg of the drug, were reported in Europe. Both the number of seizures and quantities increased over 2004-2009. In 2009 illicit methamphetamine laboratories were seized for the first time in several European countries. This is an indication that methamphetamine markets may be expanding in Europe.
At global level, in 2009, North America accounted for nearly half of global seizures of methamphetamine. Seizures in East and South-East Asia rose by more than one third and there are signs that methamphetamine is reaching the region from Africa and the Islamic Republic of Iran. West Africa is also emerging as a new source of methamphetamine for the illicit Asian markets.
Ephedrine and pseudoephedrine are the main precursors for methamphetamine. Seizures of methamphetamine precursors contained in medicinal products have fluctuated considerably from 2007 until 2010. At European level, while in 2007 hardly any preparations were recorded out of the overall quantities seized, in 2008 and 2009 the amount of preparations out of the total quantities seized increased sharply and decreased considerably again in 2010[2].
After the continued increase of seizures of medicinal products from 2007 to 2009, as a result of strengthened controls of medicinal products containing ephedrine and pseudoephedrine in several countries, particularly in Mexico and countries in Central America, the total amount of medicinal products seized worldwide decreased in 2010.
However, the increasing or decreasing level of seizures is only one indicator to illustrate that illicit manufacture is taking place in a given part of the world. The absence of a control mechanism for medicinal products containing ephedrine and pseudoephedrine remains a concern both at European and at global level.
By imposing EU control over these medicinal products, we are aiming to make it more difficult, expensive and risky for criminals to source the chemicals they need to manufacture drugs. This proposal should work as a deterrent: it focuses on preventing the diversion of precursors. It concentrates on the supply reduction of the chemicals to make drugs and not on the supply of the drugs for the consumers.
Effectively preventing the diversion of drug precursors to the production of illicit drugs aims to reduce the supply of illicit drugs. It is thus consistent with the drug policy outlined in the EU Drugs Strategy 2005-2012, providing for action to reduce the supply of precursors, and, thereby, decrease the production of drugs.
This initiative aims to regulate the external trade in medicinal products containing ephedrine and pseudo-ephedrine. These products are regulated by Directive 2001/83/EC. However, the objective pursued by that Directive is of a different nature, i.e. to safeguard public health by controlling the production, distribution and use of medicinal products in order to ensure their quality, safety and efficacy. This explains why the control mechanisms foreseen in Directive 2001/83/EC and in Regulation (EC) 111/2005 are different.
The medicinal products legislation has recently been amended by Directive 2011/62/EU which relates to the prevention of the entry into the legal supply chain of falsified medicinal products. The Directive addresses inter alia the distribution chain for medicines within the EU, importation of active substances, and introduction of medicines, i.e. medicines brought into the customs territory without the intention of placing them on the market. These provisions are focused on preventing products that fall within the definition of falsified medicinal products from entering the legal supply chain. Given that the principal issue with drug precursors is one of legitimately produced products leaving the legal supply chain, it is unlikely that these new provisions will make a significant contribution to tackling the issue of controlling medicinal products containing ephedrine or pseudoephedrine being exported or transiting through the EU.
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
- BUDGETARY IMPLICATION
- 1.1. Background
- 1.2. Scale of the problem (methamphetamine and its precursors)
- 1.3. Consistency with other EU policies
- 2.1. Consultation of interested parties
- 2.2. Impact Assessment
- 3. LEGAL BASIS AND SUBSIDIARITY
- 5. ADDITIONAL INFORMATION
A stakeholder consultation was held. This was not a public consultation, given the sensitivity and the peculiarity of the matter at stake[3]. Only the most concerned stakeholders were therefore consulted, namely national competent authorities (customs, police and health) and the pharmaceutical industry. To avoid providing sensitive information to traffickers, the responses of the stakeholders were treated confidentially.
In response to this consultation the Commission received 31 contributions. Of these, 22 were from national authorities (3 of which were partial replies) and 8 from the industry (6 manufacturing companies and 2 pharmaceutical associations).
In general terms, the industry is satisfied with the current situation but would not be opposed to improve it to the extent that it would not impose increased administrative burden on exporting companies. Among Member States' competent authorities two thirds plead for an amendment of the legislation, though to different degrees, while one third is in favour of maintaining the current situation, thus not amending the legislation.
The impact assessment report identified and assessed policy options aiming to prevent the diversion of medicinal products containing ephedrine or pseudoephedrine to the illicit manufacture of methamphetamine by introducing control measures over these products when traded between the Union and third countries while maintaining their free flow.
The impact assessment report contains five policy options. The first one provides for the so-called 'baseline scenario', where the Commission would take no action and the status quo would be maintained. Option 2 considers contributing to improve the situation through voluntary measures by Member States, while options 3, 4 and 5 consider resolving it through compulsory control measures. The last three options have been built as a crescendo as to the number and strength of the control measures envisaged. Another policy option suggesting a trade ban on these products has been considered and discarded without further analysis of its impact.
Option 1 should be excluded if the Commission was to respond adequately to the Council's request to address the weaknesses identified in the control system of the drug precursor legislation and to concerns expressed by the international community.
Option 2 would only partially address the identified problem. It suggests voluntary measures which will not be effective unless adopted across all Member States. A compulsory application of these measures cannot be enforced by the instrument foreseen under this option.
Options 3, 4 and 5 would all provide a clear legal basis for competent authorities to stop and/or seize medicinal products containing ephedrine or pseudoephedrine at export from or in transit through the Union customs territory. They would all reduce the criticism expressed by the UN International Narcotics Control Board on the alleged lack of EU action to control these products. They would all increase the chances to prevent the diversion of these products, thus reducing the supply of ephedrine and pseudoephedrine for the illicit manufacture of methamphetamine, though to different degrees.
When comparing these three options requiring legislative amendments, option 3 (possibility for authorities to stop suspicious shipments) would generate only minor administrative burden; the same can be expected for option 4 (possibility for authorities to stop suspicious shipments and pre-export notification of legal shipments), while option 5 (full control of trade in medicinal products containing ephedrine and pseudoephedrine) would impose the highest administrative burden for both competent authorities and economic operators. Even though option 5 could be considered the most effective by applying the strictest controls, the requirements would be disproportionate to the objective pursued by the present initiative. The added value provided by option 4 if compared to option 3 is that, under this option, the synergy of two combined measures increases the effectiveness of each individual measure, with a limited additional burden given that the pre-export notification system is up and running and that the number of pre-export notifications that could be seemingly sent per year by Member States' competent authorities is relatively small. Moreover, as pre-export notifications are already compulsory for scheduled substances of category 1, it would seem logical to make them compulsory also for the products containing them, such as medicinal products containing ephedrine or pseudoephedrine.
The impact assessment concluded that option 4 would be the most suitable one to address the identified problem, as it would provide for a legal basis, impose only one extra control requirement and generate hardly any additional administrative burden.
The legal basis of the proposal is Article 207 of the Treaty on the Functioning of the European Union (TFEU). Article 207 defines the EU common commercial policy. Moreover, Article 3(1) of the TFEU provides exclusive competence of the European Union in the area of common commercial policy.
Council Regulation (EC) No 111/2005 lays down rules for the monitoring of trade in drug precursors between the Union and third countries, and therefore falls under the common commercial policy.
The proposal will not have an impact on human resources and on the European Union budget and is therefore not accompanied by the financial statement foreseen under Article 28 of the Financial Regulation (Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities).
The proposal contains some other amendments aiming at facilitating the implementation of the Regulation and at increasing its effectiveness.
The proposal includes:
- the possibility to amend the Annex to the Regulation in order to react more quickly to new emerging trends in precursors diversion;
- a reference to the database, created by Regulation (EC) No 273/2004 as amended, to simplify the reporting by Member States' authorities in accordance with Article 12(12) of the United Nations Convention;
- a review clause to assess whether the amended Regulation will have been effective to prevent the diversion of medicinal products containing ephedrine or pseudoephedrine;
- the adaptation of the provisions of Regulation (EC) No 111/2005 in accordance with the rules on delegated and implementing acts under the Treaty on the Functioning of the European Union (TFEU).
The Commission has been granted implementing powers under the current Regulation in accordance with Articles 4 and 7 of Decision 1999/468/EC. As this Regulation is being amended, these powers have to be aligned in accordance with Articles 290 and 291 of the TFEU. The alignment in the proposal has been made in accordance with the provisions of the Common Understanding on Delegated Acts between the European Parliament, the Council and the Commission and Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers.
The proposal is subject to the WTO-TBT Agreement, thus subject to a notification to the WTO.