FAQ

The publicity/advertisement made for a pharmaceutical product should encourage the rational use of the drug, by presenting the medicine objectively, with no exaggeration on its properties or giving a misleading image. It should include information on the dispensing classification of the product. In this context, all elements of the publicity should be in accordance with the information of the Summary of Product Characteristics.

With article 19 of the modified law of April 11th 1983 on regulation of marketing authorization and publicity of pharmaceutical products, the government is authorized to regulate advertisement made for drugs to health care professionals.

In this context, the Règlement grand-ducal of December 15th 1992 on marketing authorization of pharmaceutical products, article 22, paragraph 1, makes it mandatory to use essential information compatible with the Summary of Product Characteristics, in the publicity for pharmaceutical products for prescribing and delivering health care professionals.

Essential information is on the one hand given by the SmPC but in addition to this, information that is not written in the SmPC could also be used, provided that it is compatible and not misleading, respecting article 5 of the modified law of December 23rd 2018 on discount and street sales and misleading and comparative publicity. An example could be new information on quality, security and/or efficacy on pharmaceutical products, in accordance with the SmPC, and approved by National Competent Authority or EU.

Essential information varies depending on intrinsic properties of a pharmaceutical product (medicine derivatized from blood, biological medicine, radiopharmaceuticals, etc.), mechanism of action, indications, therapeutical interval, galenic form, administration type, contraindications, drug interactions, frequency and severity of side-effects, eventual precautionary measures and stock conditions. This is why, article 24, paragraph 2 of the Règlement grand-ducal of December 15th 1992 indicates that medical representatives should, at a meeting with health care professional, always give or have the SmPC at disposal for every medicine presented. The SmPC remains the reference document with all essential information. Article 22, paragraph 2 describes an exception for a publicity repetition, a case where the elements presented to a health care professional might be reduced to the name of the pharmaceutical product only, the DCI if available or the brand name.

Article 24 of the Règlement grand-ducal of December 15th 1992 establishes the responsibility of the MAH for all content of the publicity of the pharmaceutical products.

In conclusion, Marketing Authorization Holders decide about the content of the publicity for a pharmaceutical product and essential information, given to health care professionals, is extracted from official SmPC and other sources approved by Competent Authority. Article 2 of the Règlement grand-ducal of December 15th 1992 lists all elements of the essential information of the SmPC.

We admit that it is not entirely possible to precisely give in advance all essential information needed for a publicity for health care professionals. Publicity is more accurately defined by article 20 of the modified Règlement grand-ducal of December 15th 1992. 

Advertisement should be analyzed separately for every pharmaceutical product, on a case by case basis, and essential information needs to be adapted to every medicine. MAH should give publicity information in accordance with the specialization of the health care professional (General Practicioner, Specialized medical doctor, pharmacist…)  

The Division of Pharmacy and Medicines is in charge of controlling the content of all submitted publicity by MAH, but will also assess the list of addressees of the advertisement, the transmission modality and the release date. The Division may give recommendations on the content of the publicity, considering the class of medicine and activity domain of the health care professional.

 

FORM

RESEARCH AND DEVELOPMENT.

Innovation is in the DNA of our business. It's how we improve the lives of patients, change the way we manage healthcare and benefit society as a whole. But our innovation gene is just the beginning. Expressing it - discovering and developing treatments that relieve suffering, prolong life and improve quality of life - takes time, skilled people, significant resources, collaboration across sectors and boundaries and often endless experimentation to find new breakthroughs.

Developing new drugs is a long, complex and risky process with no guarantee of success. It all starts with an idea. From 10,000 screened molecules to 10 that will be patented and 1 that will pass all the stages of testing and clinical trials to become a drug, the path from innovation to patient is long (12 years on average), complex and expensive. There are a number of phases in this journey.

Discovery and preclinical research

At the earliest stage, the aim is to understand a disease and how to influence it, to identify a molecule or compound to be developed, to see if it has the potential to become a drug that can change the lives of patients.

The drug candidate first goes through a series of so-called "pre-clinical" tests. These tests are a necessary step before any testing on humans.

- Experimental pharmacology: efficacy tests are carried out on inert molecular systems, on cells and cultures and, finally, on animal models. This is the first proof of concept.

- Toxicology: these studies evaluate the risks of side effects of future drugs.

- Pharmacokinetics and drug metabolism: these studies focus on the pharmaceutical properties of the molecule such as absorption, metabolism, distribution and elimination. But they also aim to prove the pharmacological properties.

If the results of these studies are positive, the drug enters the human clinical trial phase.

        2.  Clinical development

In order to resolve further uncertainties about the benefits and risks of a new treatment, it must be tested in a clinical trial. Before embarking on the clinical trial process, which is usually a three-step process, a company or academic institution must submit a protocol for regulatory review, which details how the trial will proceed. The protocol is evaluated by an ethics committee, which consists of independent experts and representatives of the lay public.

Only one in ten drugs reaches the clinical trial stage.  This starts with a small trial on healthy volunteers (phase 1) before moving on to larger and larger trials in phase 2 and 3. These are often multi-center trials, sometimes involving thousands of patients, conducted in several countries and regions, to determine whether the new drug is safe and effective. All trials must be registered in the publicly available database before the trial begins.

These three phases are carried out in hospitals or doctors' offices, under the responsibility of expert doctors: the investigators.

PHASE 1: TOLERANCE OR SAFETY

Increasing quantities of the new molecule are administered to healthy volunteers under close supervision. This phase makes it possible to evaluate the broad outlines of the product's tolerance profile and its pharmacological activity.

 

PHASE 2: PRODUCT EFFICACY IN SMALL POPULATIONS AND DOSE FINDING

This phase takes place in a small number of hospitalized patients. The aim here is to define the optimal dose, i.e. the dose for which the therapeutic effect is the best with the least side effects. Proof-of-concept studies are used to validate a new treatment hypothesis in patients.

PHASE 3: "PIVOTAL" STUDIES

In conditions as close as possible to the usual conditions of use of the treatments, the efficacy and safety are studied in comparison with the reference treatment or a placebo. This is verified on a large group of patients. Precautions for use and risks of interaction with other products are identified. The trials may cover several hundred to several thousand patients.

All clinical trials conducted in the European Economic Area must be carried out in strict compliance with Good Clinical Practice (GCP) guidelines, an international ethical and scientific quality standard for the design, registration and reporting of trials involving human subjects. Adherence to GCP means that subjects' rights are respected and that clinical trial data are reliable. Similarly, compliance with Good Manufacturing Practice (GMP) guidelines must be ensured so that products are manufactured consistently and controlled to quality standards.

During a trial, patients are randomly separated into two common groups. This randomization ensures that all recorded outcomes are due to the treatments provided and not to the method of patient selection. One group receives the study drug or treatment procedure, while the other group - the control group - does not. The control group may be offered an alternative to the study drug - including the best available therapy or, if not available, a placebo. Trials must include a wide variety of patients for whom the treatment is intended, including ethnic groups, children and the elderly.

In most trials, patients do not know whether they are receiving the treatment under study or a placebo/other known therapy. This process is known as blinding. Healthcare professionals involved in the trial may also be prohibited from knowing which patient is in which group; this process, in addition to the first, is known as "double-blinding." This protects the trial from bias.

Once the trial is complete, a team of independent, unbiased researchers analyze the results. A summary of the trial, whether positive or negative, must be disclosed in a publicly accessible database.

Only "original" drugs from the innovative pharmaceutical industry go through these long stages.

The "generic" version of a drug is a copy of the original molecule. It does not go through this long cycle of testing.

        3.  Regulatory approval

The information and results of all preclinical and clinical studies, as well as a description of the drug's manufacturing process, are compiled and submitted to regulatory agencies to demonstrate the safety and efficacy of the new drug. This constitutes a marketing authorization application (MAA), allowing the drug to be marketed and patients to have access to it.

Once a drug has been granted marketing authorization, it undergoes strict monitoring to detect any potential safety or quality problems. This process is known as pharmacovigilance and must be undertaken in accordance with Good Pharmacovigilance Practices (GPP), a set of measures defined by the EU. It is the responsibility of the company that has been granted marketing authorization to continuously collect and collate data relating to the safety, quality and efficacy of the medicine. All of this data is then accessible by the regulatory authorities.

  4.  Pharmacovigilance

Drug safety is a permanent concern for drug companies. Once a drug is dispensed to patients, pharmacovigilance accompanies it throughout its life and will also be the subject of rigorous procedures.

Any health accident related to the use of medicines is reported to the regulatory authorities within a mandatory timeframe.

Companies also submit a drug monitoring report every six months for the first two years of the drug's life, then every year for the next three years, and finally every five years for as long as the drug is on the market.

        5.  Drug Utilization Data

Data collected from patients and their use of medicines helps us to better understand diseases and patients and to inform the discovery and development of new or improved treatments.

A MAJOR RESEARCH EFFORT, SELF-FINANCED BY COMPANIES

The development of thousands of new drugs over the last 50 years has been financed by the innovative pharmaceutical industry and their ability to increase their R&D expenditure. Therapeutic innovation presents both a high cost and a major financial risk: the time required for research mobilizes large amounts of capital over a long period of time, for an uncertain result. Few drugs generate sufficient profits to cover all the research and development costs incurred.

In addition, companies can only rely on a limited number of drugs to finance their future R&D. Diversification of the companies' product portfolio allows them to minimize the risk associated with each drug. This phenomenon explains the recent mergers, which allow companies to achieve economies of scale.

Today, patent protection of molecules is one of the guarantees of financing future research, and therefore the development of new, vital medicines, with the best cost/effectiveness ratio.

R&D EXPENDITURE REPRESENTS AN AVERAGE OF 9.8% OF DRUG COMPANY SALES

The pharmaceutical industry is one of the economic sectors with the largest research effort.

Although the total research budget is lower in absolute terms than that of the automotive and aerospace industries, it represented 10% of the innovative pharmaceutical industry's turnover in 2017, compared with only 4.8% for the automotive industry.

FORM

Member Companies invest in medical and biopharmaceutical research and are committed to developing innovative solutions for unmet medical needs. They are also committed to offering their medicines in compliance with all applicable local and international rules and regulations, within a global ethical framework.

Their first priorities are the health and well-being of patients and the quality of the care they receive.

        1.  Five Core Principles

Member Companies embrace the ethical principles and are committed to:

1. Provide medicines that meet the highest standards of quality, safety and efficacy, as determined by regulatory authorities.

2. Provide reliable, balanced and scientifically valid data about their medicines.

3. Provide information that balances the risks and benefits of their medicines and their proper use.

4. Be open and transparent in their dealings with stakeholders and healthcare professionals: nothing is offered or provided by a company in a way or on terms that would have an inappropriate influence.

5. Ensure transparency of industry-sponsored clinical trials on patients.

        2.  Concrete examples.

1. Promotion only to health professionals: Information or promotion about drugs may be directed only to those health professionals who can reasonably be expected to need or be interested in the information.

2. Transparency of promotion: Promotion of medicines must always be identifiable as such.

3. Prohibition of gifts: With respect to prescription drugs, the offer, granting or promise of any gift, direct or indirect, to a health care professional or member of a health care organization is prohibited, even if its value is negligible and it relates to the practice of the medical, dental or pharmaceutical profession, in particular:

- gifts for personal benefit (such as tickets to sporting or entertainment events, social courtesy gifts) ;

- cash, cash equivalents or personal services. For these purposes, personal services are any type of non-professional service that confers a personal benefit on the recipient.

- promotional items or gadgets. For these purposes, a promotional item is a non-monetary item given for promotional purposes Sponsorship and the organization of scientific meetings by or on behalf of Member Companies are subject to Luxembourg law

4. 4. Informational or medically useful material:

Items of medical utility may be given to Healthcare Professionals and members of healthcare organizations only if such items:

(i) are directly related to their education and patient care;

(ii) are of low value; and

(iii) are not part of the basic materials and equipment required by any professional in their routine practice

5. Transparency. Transparency: Without prejudice to the application of legal and regulatory provisions, particularly those relating to privacy, pharmaceutical companies are required to document and publish transfers of value that they make, directly or indirectly, to health care professionals or organizations.

6. Hospitality: Members are permitted to offer hospitalitý to healthcare professionals, as long as this hospitalitý remains at a reasonable level (Maximum 45 EUR per person at noon and 90 EUR per person in the evening, including drinks.)

FORM

CANCER

● Every year in Luxembourg, about 3,000 new cases of cancer are discovered. In 2019, 1,139 people died from cancer in Luxembourg.

In men, prostate cancer, lung cancer and colorectal cancer rank 1st, 2nd and 3rd respectively among invasive solid tumors in terms of incidence. Among women, breast cancer, colorectal cancer, and lung cancer occupy these ranks.

● This makes cancer the leading cause of death, accounting for 27.6% of all deaths. Compared to 2018, the number of cancer deaths remained stable. Data on the survival time of cancer patients are not available in Luxembourg for all types of cancer, at the national level. Some hospitals, however, calculate survival time for their patients for certain types of cancer.

● 60% of breast cancers, 44% of colon cancers and 47% of rectal cancers are detected at an early stage.

Issues

● Develop prevention

       o By reducing risk factors: In Luxembourg, the second National Cancer Plan 2020-2024 is being developed as an extension of the first National Cancer Plan 2014-2018. Several axes are defined in this plan:

Axis 1: governance, resources, monitoring & reporting

Axis 2: eMedicine

Axis 3: Rights, information & training of patients

Area 4: Prevention, screening & epidemiology

Axis 5: Diagnosis

Axis 6: Treatments, multidisciplinary care, support care & patient support

Area 7: Onco-Pediatrics & Oncogeriatrics

Axis 8: Clinical and translational research

       o Increasing the rate of vaccination coverage against HPV.

This vaccine prevents between 70 and 90% of the infections involved in uterine cancers. Through vaccination, it is hoped to achieve a decrease in the circulation of HPV in the population and thus an action on the incidence of cervical cancer.

● Detect cancer as early as possible

Diagnosing cancer as early as possible increases the chances of cure.

For the time being, this early detection is based on organized screening of cancers for which a test exists and on raising public awareness of certain warning signs.

In Luxembourg, three cancers are subject to organized screening in the general population: breast, cervical and colon cancer.

For cancers for which there are no simple or reliable tests, the aim is to :

       o finding specific biomarkers allowing the development of liquid biopsies for very early detection of cancers;

       o using artificial intelligence, in order to exploit all available data and develop algorithms that will allow individual screening.

● Expanding the therapeutic arsenal for personalized medicine

Personalized medicine aims to offer patients a treatment adapted to their tumor's abnormalities. It is currently based on two types of treatment: targeted therapies and immunotherapy.

Targeted therapies block the growth or spread of the tumor and specific immunotherapy treatments restore the effectiveness of the immune system.

These treatments, which are truly disruptive innovations, are destined to become the pillars of cancer treatment, but they still face several challenges:

      o Limiting adverse effects: targeted action limits damage to healthy cells, as is the case with conventional chemotherapies, but it is not without adverse effects.

      o Find predictive biomarkers of treatment response to identify patients most likely to benefit from treatment and avoid exposing non-responders to treatment.

      o Understand tumor heterogeneity to anticipate treatment resistance.

Indeed, a tumor is composed of several types of cells in constant evolution.

Actions

● The innovative pharmaceutical industry maintains a particularly active research with 3,463 industrially promoted clinical trials in development.

● It is investing in the use of digital technology at all stages of drug development, particularly to design more targeted clinical trials.

● It provides patients with reliable and up-to-date information.

● Taking into account patients' quality of life, in cooperation with all stakeholders in their care pathway, is one of their priorities.

Today, many cancers are cured and mortality continues to fall thanks to earlier diagnosis and more effective and targeted treatments. We are also witnessing the development of "customized" treatments thanks to a better understanding of tumors.

AIDS

Figures

● 52 treatments and vaccines are under development worldwide.

Background

● A person infected with HIV (human immunodeficiency virus) is said to have "AIDS" when their immune system weakens and is no longer able to protect that person from disease and infection.

● In 2018, 37.9 million people worldwide were living with HIV, including 1.8 million children (under 15 years of age), 24.5 million patients were on triple therapy, about 60% of the infected population. 

● Since the start of triple therapy in the late 1990s, with nearly 15 doses of medication taken at set times day and night, treatment has progressed significantly.  Since 2018, a new once-daily combination has significantly improved patients' quality of life. Other long-acting combinations even allow injections every month or two. 

● Today, with treatment, people with HIV remain HIV-positive but do not get AIDS. Medications stop the progression of HIV and its impact on the body, but do not provide a complete cure. HIV infection is now considered a chronic disease: one that requires lifelong treatment.

Issues

● Develop drugs with few side effects that could be discontinued while keeping the virus under control, thereby preventing transmission.

● Continue research and combine artificial intelligence and new technologies to prevent and treat HIV.

● Finding a vaccine

The search for an AIDS vaccine is complex.

A study published in December 2018 in the journal Immunity showed, for the first time, the ability of an experimental vaccine to induce, in primates, the production of antibodies capable of protecting them from infection by a virus that is difficult to neutralize. 

● Reinforce prevention messages for young people

PrEP (pre-exposure prophylaxis) is a preventive treatment for HIV-negative people to avoid any risk of HIV infection.  Combination prevention today is based on three main strategies:

1. condom use,

2. use of screening,

3. treatment progress.

Actions

● The innovative pharmaceutical industry feels strongly invested in combining antiretrovirals in bi, tri, and then quadri-therapies that are increasingly effective and compatible with an improved quality of life on a daily basis for those affected.

● 52 treatments and vaccines are being developed worldwide, including 32 antiretrovirals, 16 vaccines and 4 gene therapy drugs.

● Goals for 2030 include:

○ an HIV vaccine,

○ viral load testing for all children exposed to the virus in the most affected countries in their first two months.

● The innovative pharmaceutical industry supports the 90/90/90 rule of UNAIDS, the UN agency dedicated to fighting the disease:

o that 90% of people living with HIV know their HIV status;

o 90% of infected people are treated;

o 90% of people receiving antiretroviral treatment have their viral load permanently suppressed.

Sources: Information taken from the website of the innovative pharmaceutical industry in France, Leem : www.leem.fr

FORM

Under the new regulation on veterinary medicines, The European Commission is to establish a number of criteria on the basis of which the use of certain antibiotics will be restricted in humans. A proposal to rebut these criteria is now on the table of the European Parliament, which will have the effect of limiting the number of antibiotics that can still be used to a greater extent than the Commission envisages.

This proposal has been developed on the basis of extensive advice from the European Medicines Agency (EMA), and strikes a good balance between the protection of human and animal health. This is in contrast to the current proposal. If adopted, it would make it more difficult for veterinarians to treat animals properly, with considerable consequences for the health and welfare of the animals concerned. In addition, the antibiotics that are still allowed to be used in animals would no longer be able to be used as precisely as they are today, increasing the risk of developing resistance.

Hereby you find the link to Ministry of Health enabling you to add medicinal drugs on the luxemburgish 'positve list': LINK as well as the doucment to be used: DOCUMENT

Hereby you find the link to Ministry of Health to request a price change on medicinal drugs on the luxemburgish 'positve list': LINK as well as the doucment to be used: DOCUMENT

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FEES - REDEVANCES

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