Negotiation Chapter 28 – Meeting in the Serbia Palace


Meeting of representatives of the civil society organisations interested in the negotiation process of accession to the European Union within the section 28 and the government accession negotiation team took place in the Serbia Palace on March 2nd 2015 and was organised by the Office for cooperation with the civil society. Chapter28 pertains to consumer and health protection.

The meeting was opened by Ivana Ćirković – head of the Office for cooperation with the civil society, Vesna Kovač – state secretary in the Ministry of commerce, toursim and telecommunications and coordinatior of negotiations peratining to chapter 28, and Predrag Sazdanović – Assistant of the Minister of Health. Most attention of the participants was attracted by the speach by Mr. Sazdanović, and most of the questions were driected at him, but the Assistant Minister did not have to answer all of them completely.

In the second half of the meeting, Mr. Dalobor Matić from the Ministy of external affairs of Croatia presented experiences fro his country in the negotiation process and the challenges they faced within this chapter, primarily in the domain of consumer protection. The negotiation process is very significant and presents a good opportunity to improve the healthcare system with the support and constructive participation from the civil society. However, with all praises to the Office to organize this meeting, there is a feeling that representative of the government should be more open to suggestions and problems of the civil society in order to achieve good progress and expected social reforms.

Representing Q-Club on this meeting was Nenad Petković.


Meeting of the Republic Healthcare Fund and Patient Organisations


The new director of the Republic Healthcare fund has invited members of the Patient Organisations in Serbia to a meeting which took place in the offices of the Healthcare Fund on February 26 2015. The goal of this meeting was mutual introduction as well as initial presentation of problems that patient organizations have. There were more than 30 representatives of various organizations, and representing the Healthcare Fund, along with the director were Sanja Mirosavljević and Aleksandra Gazivoda – both of them working on cooperation with patients.

In her introduction speech, the director, Ms Lazić stressed that her commitment was to improve relations and cooperation with patient organizations, which was well received by patient groups representatives. The general conclusion was that this direct cooperation between the Fund and patient groups was a good initiative. However, for further improvements thematic meetings would be needed – such meetings would gather representatives of patient organizations with similar problems, and they would be an opportunity to consider specific problems. The Republic Healthcare Fund took upon itself to schedule these meetings in the forthcoming period.

Representing Q-Club on this meeting was Nenad Petković.


The HIV Prevention Manifesto: we need PrEP now!


Open letter from HIV & LGBT European community organisations and other concerned Europeans to pharmaceutical industries, European and national institutions.


In recent years, there has been considerable debate about the role that antiretroviral drugs (ARVs) could play in combined HIV prevention strategies. One way of using them is as pre-exposure prophylaxis (PrEP); this involves the use of specific ARVs to reduce the risk of infection in HIV-negative people who are exposed to HIV. In 2012, the US Food and Drug Administration (FDA) announced its approval of daily oral tenofovir and emtricitabine (Truvada(R)) for PrEP. In Europe, this combination is not available for prevention except to people enrolled in scientific studies.

Recently, two major European scientific studies, the English PROUD trial and the French IPERGAY trial, reported the highest effectiveness rates yet seen in studies of pre-exposure prophylaxis (PrEP) for HIV.

These results are ground-breaking. A European licence for a measure that was approved by the US Food and Drug Administration in 2012, and which is already being used by at least 12,500 people in the US, is overdue.

Some of the questions raised by a possible licensed use of ARVs for PrEP in Europe are complex. How will people be assessed for PrEP? Where and how will it be delivered? Who will pay for it? How do we align it with the specific situations of different affected communities? None of these issues are unmanageable and, given the additional opportunity for HIV prevention and sexual health that PrEP is opening up, questions around its implementation and impact deserve an open discussion between communities affected by the HIV epidemic, health professionals, policy-makers and the companies producing the ARVs used for PrEP. Meanwhile, steps must be taken to make PrEP available.

This call from HIV and LGTB community organisations in Europe to both public health authorities and pharmaceutical companies is released as part of efforts to improve HIV prevention, sexual health and health seeking behaviour among gay men and other men having sex with men who are at risk of HIV infection.

As European community-based organisations we publicly raise the following points:

  • The number of new HIV infections in Europe continues to increase, particularly among key populations (men who have sex with men, people in prison, people who inject drugs, sex workers, transgender people and migrants among others).
  • We need to improve the HIV prevention tools and strategies for the key populations at increased risk for HIV acquisition.
  • We need to have additional prevention tools and to develop strategies combining them. This is the only way to end the HIV pandemic.
  • The effectiveness of PrEP has been proven in high-quality randomised studies, in Europe; they show that PrEP dramatically reduces the risk of HIV transmission.
  • PrEP is needed in Europe now and we are demanding it. The PROUD and IPERGAY studies and other community-based research show that there is demand for PrEP from people at high risk for HIV.
  • There already exists some informal use of PrEP. This informal use lacks adequate medical follow-up. Key populations need to choose if they want to use PrEP, and do it safely

We call on all stakeholders to make PrEP available and accessible in Europe:

  • We ask that Gilead, the manufacturers of Truvada®, to immediately file for a PrEP indication for Truvada® to the European Medicines Agency (EMA). We ask the EMA to clarify the regulatory pathway for access to PrEP.
  • We ask that pharmaceutical companies work with independent researchers to conduct implementation research on PrEP as part of programmes to make it available. PrEP must be effective, safe and easy to use.
  • We ask the European Centre for Disease Control and Prevention (ECDC) to initiate a working group on European PrEP guidelines. This group should include civil society and clinical organisations. These guidelines should:
    • Help define when PrEP provides most benefit;
    • Address access across Europe;
    • Define a follow-up protocol for people taking PrEP.
  • We ask European governments to examine ways to make PrEP reimbursable for those who need it.
  • We demand that PrEP is integrated into a wider and holistic sexual health strategy, which should also include counselling, testing, treatment and vaccination for STIs, condom and lubricant provision, post-exposure prophylaxis and self-support groups. No single prevention method should set in competition with others.

The successful implementation of combination HIV prevention needs evidence and evidence-based strategies and scientific and civil society organisations need to work together to provide them. Key populations need up-to-date information on new choices in order to take the best decisions to improve the quality of their health, happiness and social efficacy.

Q-Club is one of the signatories of this initaitve. You can see the manifesto here.


150 HIV Organizations Urge Continuation of D:A:D Study


HIV drugs are used in combinations, so it is right that the companies who make and sell these drugs collaborate on this study on long-term safety.

We urge the following companies to continue funding this vital study: AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck Sharpe Dohme and ViiV Healthcare.

The funding must also make it possible to add new patients to the D:A:D database for another five years, since many will be starting treatment with newer HIV drugs.

For over 15 years the D:A:D study has been a remarkable collaboration.

Since 1999, it has included:

  • The US and European drug safety bodies (the FDA and the EMA)
  • Drug companies that manufacture HIV drugs
  • Independent scientists and researchers
  • HIV community representatives

What has the D:A:D study shown so far?

D:A:D was originally set up to look at HIV drugs and the risk for liver and heart disease.

Since then, D:A:D  has answered many other long-term safety issues.

These include:

  • The risk of rare side effects from individual drugs
  • HIV drugs and body shape changes
  • HIV drugs and blood pressure
  • The long-term safety of HIV drugs and the liver
  • HIV and hepatitis coinfection
  • A new HIV-specific calculator for heart disease risk
  • Causes of, and risk for, death among HIV-positive people
  • Making sure that causes of HIV-related deaths are recorded accurately
  • HIV drugs and kidney disease
  • HIV and cancers, especially non-AIDS cancers
  • HIV drugs and diabetes
  • HIV drugs and stroke

D:A:D combines results from over 50,000 HIV-positive people from 11 research networks in Australia, Europe and the US.

Although the companies no longer have to fund this study, we think D:A:D is too important to let close.

Results from D:A:D have been used to change HIV treatment guidelines and the way people are treated by their health care providers.

D:A:D has developed practical tools for estimating risk of heart and kidney disease in HIV-positive people.

D:A:D has also reported new side effects that were not found when the drugs were first studied, including:

  • Heart disease with abacavir, ddI, saquinavir, lopinavir/ritonavir, and indinavir/ritonavir
  • The risk for diabetes with d4T
  • Kidney damage with tenofovir, atazanavir/ritonavir, and lopinavir/ritonavir

D:A:D has also showed that other drugs did not have these side effects.

D:A:D has also shown whether guidelines are being followed.

  • It reported on use of lipid lowering drugs among HIV-positive people
  • It provided evidence that stopping smoking has similar impact on heath for HIV positive people as the general population
  • It showed that people at high risk of suicide were not using efavirenz (and that efavirenz did not increase suicide rates in people who were not at high risk)

What is needed now?

We need this essential study to continue.

We need new patients to be included to answer the same questions for the newest drugs and combinations.

Why do we need D:A:D to continue?

D:A:D is critical for many reasons:

  • D:A:D results gives people the confidence to start HIV treatment. It is an independent study that produces real-life data (including people who are not well-represented in studies, including women).
  • Because HIV treatment is now being used earlier and at higher CD4 counts.
  • Because D:A:D can detect new safety concerns that we might not yet know about.
  • D:A:D can look at risks in specific groups of people living with HIV. For example, by age at infection, gender, ethnicity, race, sexual orientation, illicit drug use, and in younger and older people.
  • ART is lifelong. We therefore need longer-term information about drug- and drug class-specific safety and tolerability, including additional data on reversibility of toxicities when drugs are switched.
  • D:A:D can identify safety concerns or rule out concerns with new drugs or drug classes. This includes the newest integrase inhibitors (raltegravir, elvitegravir, dolutegravir). It can look at new drugs like etravirine, cobicistat and the new version of tenofovir (TAF).
  • D:A:D can look at long-term outcomes after treatment with new hepatitis C drugs. More than 4,000 people in D:A:D are infected with both HIV and hepatitis C.
  • We need to know more about generics and co-formulated drugs.
  • We need to know more about drug-drug interactions and long-term safety. This is particularly true as we get older. By 2016, more than 5,000 people in D:A:D will be over 60. Half of the people in D:A:D will have been using HIV meds for more than 10 years.

If D:A:D is allowed to end, it will be lost forever.

If there is a new safety issue, we will not be able to rebuild D:A:D—16 years of results will be lost.

For these reasons, we urge the above companies to support the D:A:D study for another five years.

Continuing to fund D:A:D makes a powerful statement about your company’s commitment to people living with HIV/AIDS.

Your support sends a clear message about supporting our communities and health care providers.

This research is invaluable to millions of people living with HIV/AIDS. It has a direct effect on our lives.

We hope to hear that you are willing to continue supporting D:A:D.

Q-Club is one of the signatories of this initaitve. You can see the complete list here.


ARV treatment literacy training


Training “ARV treatment literacy“ took place in Belgrade from 6th to 8th of February 2015. The training was organised by Association Q-Club and with the support of the European AIDS Clinical Society (EACS).

Goal of the training was to educate participants on how to adequately use ARV treatment, to familarise them with basic principles of peer counseling and enable and empower them to consult, educate and give acurate and adequate information on ARV treatment and adherence to this treatment.
Adequate use of ARV treatment as well as complete adherence to it is crucial for everyone living with HIV, because they dramatically improve their quality of life and prevent further progression of the infection.

There were 31 participants of the training (four of them doctors, four of them peer educators, and 23 activists). Participants came from all over Serbia, but also from neighbouring countries (Bosnia and Herzegovina, Croatia, Montenegro and Macedonia), which gave a regional character to this training.
The training included lectures, workshops and practical excercises presenting crucial information on adequate use of ARV treatment, adherence as well as basic concept on HIV and AIDS.

Some of the most important lectures were “On natural course of the HIV infection and initiating treatment” by dr Dubravka Salemovic, and “Introduction to ARV treatment, groups of drugs and resistance” by dr Jovana Kusic as well as “Immune system, virology, CD4 count and viral load” by prof. dr Djordje Jeftovic, but also “Adherence” by dr pharm. Gordana Dragovi Lukic. These lectures gave the participants the most important terms and concepts regarding HIV, origins, transmission, progression and revolution in discovering ARV medicines which enabled practically normal lives for people living with this illness.

The training participants learned about some of the newest medical achievements regarding HIV, like Treatment as Prevention, pre exposure prophylaxis (PrEP), and post exposure prophylaxis (PEP), but also on the importance of clinical research methodology.

On the last day the participants had a chance to learn from experienced peer educators, and to learn the newest techniques and mechanisms in peer counseling and by participating in role plays, workshops and examples learn how to act in various potential situation and be prepared to adequately react and help people with issues and problems.

People who know about their treatment can understand its significance, and are very empowered. They can adequately react to all changes they go through, and to make informed decisions about the course of their treatment, habits, responsibility as well as to help empower people from their community and share their knowledge and experience with other, thus motivating other people to learn their HIV status and start treatment in time, which will enable them to lead long and high quality lives. .


Five year report