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Q&A on veterinary medicines and medicated feed proposals

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cowsToday (10 September) the Commission adopted proposals on veterinary medicines and medicated feed, which aim to improve animal health and public health, as well as the internal market.

1) Veterinary medicines proposal

Why are new EU rules on veterinary medicines needed?

At present, there is an insufficient number and range of medicines to prevent and treat diseases in animals in the EU. This is especially the case for animals considered as ‘minor species’ such as bees, fish and turkeys. The lack of suitable veterinary medicines results in poorer animal health and welfare, increased risks for human health, and economic and competitive disadvantages for EU farmers.

In addition, although EU rules on veterinary medicines have been in place since 1965, stakeholders and member states claim that a disproportionate regulatory burden is hampering innovation. The Commission acknowledges that current rules for veterinary medicines place an excessive administrative burden on the veterinary pharmaceutical industry, which in turn puts EU farmers at an economic disadvantage, and aims to amend the situation with this proposal.

What does the Commission hope to achieve with this proposal?

Aside from the overarching aims of helping the internal market work better, while protecting animal health and public health, the purpose of this proposal is three-fold:

1) To simplify the regulatory environment and reduce administrative burden – in other words, to reduce red tape;

2) to stimulate the development of new veterinary medicines, including those for limited markets (minor use and minor species), while keeping those already on the market, and;

3) to facilitate the circulation of veterinary medicines across the EU, through better authorization procedures, and clear rules on modern forms of retail, i.e. internet sales.

What exactly will change?

The new legislation pays particular attention to combatting the development of antimicrobial resistance (AMR) in animals and humans. With the new rules it will be possible to restrict the use of certain antimicrobials in animals that are reserved for the treatment of human infections.

In addition, to reduce red tape:

  • Streamlined marketing authorisation procedures will allow companies to place and maintain a veterinary medicine on the entire EU market, and;

  • pharmacovigilance rules (the monitoring of adverse effects of veterinary medicines on the market) will be simplified.

To stimulate the development of new medicines:

  • Special rules for the authorization of veterinary medicines for small markets such as apiculture and aquaculture will be introduced, and;

  • a better reward mechanism will be put in place, i.e. extended data protection to innovative veterinary medicines, that will make the companies’ investments worthwhile economically.

To help the circulation of animal medicines across the EU:

  • rules are introduced to facilitate the internet retailing of veterinary medicines within the EU.

How will the new rules address AMR?

The proposal gives new regulatory tools to the Commission and member states to reduce the risks to human and animal health of the use of antimicrobials in animals. The tools should drive down development and spread of antimicrobial resistance in the veterinary sector.

Who will benefit from the new rules?

Animals, farmers, pet owners, pharmaceutical companies and other businesses will benefit from the revised legislation on veterinary medicines.

For animals, the benefit will come from the increased number and quality of medicines available to treat them.

The changes will benefit veterinary surgeons, farmers (in particular those farming animals considered to be minor species such as bees, goats, turkeys) and pet owners, who will have better access to veterinary medicines to treat animals.

Human health will improve through rules aimed at keeping antibiotics effective.

The pharmaceutical companies will benefit from significantly lower costs related to getting their medicines authorised and keeping them on the market.

Other businesses will benefit from improved competition and the circulation of veterinary medicines across the EU, and the optimal functioning of the internal market.

Whose views were taken into account?

A public consultation was conducted in 2010, to gather the views of all relevant stakeholders, including farmers, pet owners, pharmaceutical companies and other businesses.

For more information on veterinary medicines:

http://ec.europa.eu/health/veterinary-use/index_en

2) Medicated feed proposal

Why are new EU rules on medicated feed needed?

After veterinary prescriptions, medicated feed is an important route for administering veterinary medicines to animals. An update of the medicated feed legislation which is now nearly a quarter of a century old (the current Directive 90/167/EEC was adopted in 1990) is long overdue. Differing national regimes have negatively affected the internal market and public health is not properly guaranteed with the current rules. Modernisation is needed to reflect technical and scientific progress in the past decades, so that harmonised rules continue to ensure the appropriate safety level of medicated feed in the EU.

As well as being important for animal health, this review is vital for the optimal functioning of the internal market to foster competitiveness, innovation and economic growth in the concerned industries.

Since the 1990 Directive came into force, the situation in the majority of EU countries has gradually deteriorated: scattered and diverging rules have affected the efficient treatment of animals and the availability of medicated feed at competitive prices. In addition, the development of antimicrobial resistance (AMR) has increased dramatically. Finally, under the current system, pet owners in most EU countries cannot treat their animals comfortably and efficiently with medicated pet food.

A consistent set of EU rules, restricting EU action to the minimum, as aimed for with this review, will have both economic and health benefits.

What does the Commission hope to achieve with this proposal?

The proposal is to repeal and substitute Directive 90/167/EEC with a modern Regulation covering the manufacture, placing on the market and use of medicated feed.

By proposing a harmonised set of provisions for the manufacture of medicated feed at the appropriate quality and safety level, the Commission aims to clarify the field for all manufacturers and support viable and economical medicated feed production. The proposed Regulation should allow veterinarians to choose the best way to treat diseased animals taking into account local conditions in each member state.

Furthermore, the Commission aims to improve legal certainty and clarity for the producers of medicated feed so that they are no longer confused by diverging and/or vague national rules. Exaggerated provisions in some areas will be eliminated so that medicated feed can be produced economically. In parallel, lax rules which lead to negative impacts on animal and public health will be tightened. Finally, the Commission hopes to boost innovation through the explicit permission to use medicated feed for pets.

What exactly will change?

The Regulation will explicitly include medicated feed for pets and it will introduce stricter measures to ensure the correct use of medicated feed. In addition, anticipated production, mobile mixers, on-farm manufacturing of medicated feed and specialised distributors will be allowed EU-wide. Finally, the Regulation will set state-of-the-art measures for the homogeneity of medicated feed and scientifically derived carry-over limits for veterinary medicines in ordinary compound feed.

How will the new rules address AMR?

The proposal addresses AMR by tackling the misuse of antimicrobials in three ways. Firstly it bans the use of medicated feed as a preventative measure or as a growth promoter. Secondly, it establishes an EU-wide residue limit for veterinary medicines in ordinary feed. Finally, it tightens the rules for prescribing and handling medicated feed with antimicrobials.

Who will benefit from the new rules?

Farmed animals - including in aquaculture, pets, farmers, pet owners, veterinarians, businesses producing medicated feed and citizens will benefit from the revised legislation on medicated feed.

The availability of good quality medicated feed at competitive prices will help farmers and lead to better treatment of diseased farm animals.

As treatment can be included in pet food, pets with chronic diseases will no longer have to swallow pills or other forms of medicine, making life easier for them and their owners.

Clearer rules will be an advantage for new companies and also existing companies that wish to expand their business.

Finally, the benefits will extend to public health due to measures to fight AMR.

Whose views were taken into account?

Many stakeholders were consulted during the preparation of the proposal, including farmers and aquaculture organisations, feed and veterinary medicine industry, veterinarians, consumer and pet owner organizations. All member states, Norway and Switzerland were also consulted.

In addition, an open web-based stakeholder survey took place in 2011 with contributions from normal citizens as well as EU-level associations. Finally, studies, data and scientific opinions from the European Food Safety Authority and the European Medicines Agency have been used as input for the proposal.

For more information on animal nutrition.

Drugs

Demystifying the drug menace: Insights from convicted drug sellers

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Recent and ongoing issue pertaining to narcotic drug usage and drug selling in Indian Film Industry has caught the attention of entire South East Asia. One recent report written by Gan in American Journal of Preventive Medicine indicates that the cost of drug abuse is more than $740 billion annually, writes Indian Institute of Management-Rohtak Director Professor Dheeraj Sharma.

Substance abuse results in additional burden on healthcare costs, crimes, and lost productivity. In last decade, India has witnessed several instances of increased availability of drugs and increased number of arrest, trials, and conviction under the Indian Narcotic Drugs and Psychotropic Substances Act.

Given the paucity of studies related to illegal drugs and drugs selling in India, an effort was undertaken by the author with his research team that was involved in jail related projects from 2011 to 2016 in various states, to examine the issue of illegal drugs and drugs selling from the perspective of those either convicted of such offenses. Data for the survey were collected from convicted drug peddlers across three states in India – Punjab, Gujarat, and Delhi.

They were repeatedly assured that their responses for this survey shall remain anonymous and confidential. Data were collected by a team of research associates trained in the local language of the state. Brislin protocol using back translation was followed to translate the questionnaire. A total of 872 responses were collected across the three states in India. All these 872 were convicted under Indian Narcotic Drugs and Psychotropic Substances Act. The participation for the survey was voluntary.

The results indicated many counter-intuitive insights. First, 78.10% of drug peddlers reported that they used to consume drugs and selling of drugs was limited to those amongst their friends and family. Of these, around 56.54% of respondents became drug peddlers as a result of being a regular drug user. A majority of the respondents (86.70%) argued that they were trapped into drug trafficking by their drug suppliers with whom they had frequent interaction owing their consumption habits. The survey questionnaire also included questions on understanding the nature of the drug trade. 77.06% of the respondents asserted that drugs are not indigenous and most of the drugs are brought from other countries. 81.88% also reported that the drugs they used to sell were routed to India from other foreign countries.

The peddlers were also asked to give inputs relating to the country they think the drugs are infiltrated in India. Majority of the drug peddlers (83.94%) reported that the drugs are infiltrated in India from Pakistan. This was followed by Nepal (5.05%), and Afghanistan (4.24%). The detailed distribution of the countries is shown in the graph below. Similarly, we also asked them to report how drug suppliers operate and were asked to rank them based on the frequency of the method used.

For our analysis, we considered the mean ratings of all the respondents to rank the modus operandi of drug peddlers in India. The results show that cross border transactions are the most common form of operation. This is followed by tourists, Illegal, college students, and business people. The most favorable place to sell drugs according to the respondents were (ranked from best to worst): 1 = Pubs and Bars, 2 = Restaurants and hotels, 3 = Colleges and Universities, 4 = Drug rehab centers, 5 = schools.

The drug peddlers were also asked questions pertaining to the profitability of the drug trade. Almost the majority of the respondents reported that on an average a profit of more than 10 lakhs is reaped from selling drugs worth INR 1 lakh. It demonstrates that the drug trade has a profitability of more than 1000 percentage. Lastly, two questions pertaining to the society and drugs were also asked. More than 85% of the respondents (86.12%) believed that music that promotes drugs has increased the drug consumption among the youth.

They contended that consumption of drugs was accompanied by music that talked about drug use and absurdity of life. On a similar note, 79.36 percent believed that Bollywood movies that glorify drugs has resulted in an increased intention to consume drugs. Specifically, the respondents reported that almost all of their clients and they themselves were trying to imitate some actor/actress from Bollywood and that drugs would result in them feeling confident about themselves. On measurement scale for self-esteem, most respondents reported very low self-esteem (scale of 1 to 7 average score was 2.4).

The study does provide some insights from the perspective of those convicted in the illegal drug related cases. Consequently, it may be useful to counsel individual at early age, particularly in schools about the menace of drug abuse. Also, health facilities and provision of rehabilitation must be strengthened. Given that some Bollywood movies play a role in glorification of consumption and trade of illegal drugs, akin to the warning that is delayed for cigarette smoking in movies, there needs to be similar warning when characters are shown consuming drugs.

In other words, the viewers should warned of penalties that arise from consumption and trade of drugs. More specifically, random drug tests in institutions could be instituted. Also, given that majority of the drugs are infiltrated from neighboring countries, the border deterrence could be enhanced. Further, college students and pubs are the most common target consumer segment for drug peddlers. Hence, the administrators of academic institutions should take appropriate measures and test for drug abuse.

Also, pubs should be regulated. Finally, given that drugs are a lucrative trade, it is likely to see more prevalence in places where there is wealth. Hence, metropolitan cities need to develop special units or strengthen the existing special units for dealing with illegal drug cases.

  • The views expressed in this article are those of the author alone and do not reflect the opinions of EU Reporter.

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Drugs

Fight against illicit drugs: Launch of the European Drug Report 2020  

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On 22 September, Home Affairs Commissioner Ylva Johansson participated in the virtual launch of the European Drug Report 2020, together with Laura d'Arrigo, chairwoman of the European Monitoring Centre for Drugs and Drug Addiction's Management Board, and the Agency's Director Alexis Goosdeel.

Promoting our European Way of Life Vice President Margaritis Schinas said: “Organized crime groups quickly adapted their drugs operations to the new situation brought by the coronavirus pandemic. Under the Security Union Strategy, we are working to reduce both the demand and supply of illicit drugs.”

Commissioner Johansson said: "The high levels of cocaine and heroin seized show that criminals continue exploiting supply chains, shipping routes and large ports to traffic drugs, threatening the health and security of those living in Europe. Modern organized crime needs a modern organized response. This is why we are working with our European Agencies to dismantle drug trafficking networks and disrupt production while improving prevention and access to treatment.”

The European Drug Report analyses recent drug use and market trends across the EU, Turkey and Norway. This year's report shows an increase in cocaine availability with seizures at a record high amounting to 181 tonnes, an almost doubling of heroin seizures to 9.7 tonnes and high availability of high purity drugs in the EU.

It also explores the appearance of novel synthetic opioids, of particular health concern and addresses the challenges caused by the coronavirus pandemic.  The report itself is available online, together with a full press release by the European Monitoring Centre for Drugs and Drug Addiction.

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coronavirus

European Commission secures EU access to #Remdesivir for treatment of #COVID-19

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On 28 July, the European Commission signed a contract with the pharmaceutical company Gilead to secure treatment doses of Veklury, the brand name for Remdesivir. As from early August onwards, and in order to meet immediate needs, batches of Veklury will be made available to member states and the UK, with the coordination and support of the Commission. The Commission's Emergency Support Instrument will finance the contract, worth a total of €63 million.

This will ensure the treatment of approximately 30,000 patients presenting severe COVID-19 symptoms. This will help to cover the current needs over the next few months, while ensuring a fair distribution at EU level, based on an allocation key, taking into account the advice from the European Centre for Disease Prevention and Control.

The Commission is now also preparing a joint procurement for further supplies of the medicine, expected to cover additional needs and supplies as from October onwards. Health and Food Safety Commissioner Stella Kyriakides said: “In recent weeks, the Commission has been working tirelessly with Gilead to reach an agreement to ensure that stocks of the first treatment authorised against COVID-19 are delivered to the EU. A contract has been signed yesterday, less than a month after the authorization of Remdesivir, which will allow the delivery of treatments from early August for thousands of patients. The Commission is leaving no stone unturned in its efforts to secure access to safe and efficient treatments, and is supporting the development of vaccines against coronavirus. Yesterday's agreement is another important step forward in our fight to overcome this disease.”

A press release is available online.

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