Over 30 drugs waiting for authorization from the Portuguese National Competent Authority INFARMED

By Marcio Barra

More than 30 new drugs, some with novel mechanisms of action which are already used in other European countries, are currently waiting for authorization by the Portuguese National Competent Authority, some for more than a year. The president of the board of APIFARMA, João Almeida Lopes, in a newspiece on the SIC tv channel commented that he believes these delays are due to economic reasons.

Some of the delays extend over a year, whereas current law sets a 75 day time limit for approval.

Below is a list of the drugs currently waiting for commercialization approval in Portugal:

 

Brand name	Molecule	Indication	Marketing Authorization holder	Reported reason for delay
Zydelig	Idelalisib	Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (a cancer of a type of white blood cells called B lymphocytes) used in combination with another medicine (rituximab)	Gilead	The first contract proposal was presented by INFARMED in September 2015
Affinitor	Everolimus	Affinitor is a cancer treatment for advanced breast cancer in women who have been through their menopause.	Novartis	Contract was received. Process not yet concluded
Votubia	Everolimus	Used to treat benign tumours caused by the genetic disease tuberous sclerosis	Novartis	Economic study not yet started
Cosentyx	Secukinumab	Moderate to severe plaque psoriasis	Novartis	Parity with the comparator
Cosentyx	Secukinumab	Ankylosing spondylitis when conventional treatments do not work well enough.	Novartis	Economic evaluation not yet started
Xolair	Omalizumab	Chronic urticaria	Novartis	–
OFEV	Nintedanib	Idiopathic pulmonary fibrosis (IPF)	Boehringer-ingelheim	Orphan indication
Vargatef	Nintedanib	Cancer medicine used to treat adults with non-small cell lung cancer.	Boehringer-ingelheim	–
Praxbind	Idarucizumab	Reversal agent for Pradaxa	Boehringer-ingelheim	–
Giotrif	Afatinib	Non-small cell lung cancer	boehringer-ingelheim	–
Xofigo	Radium-223 dichloride	Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases	Algeta and Bayer	Waiting for a cost minimization analysis from INFARMED. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Stivarga	Bayer	Gastrointestinal stromal tumor	Bayer	Currently under economic evaluation and Waiting the opinion of the Comissão Nacional de Farmácia e Terapêutica
Stivarga	Bayer	Colorectal cancer	Bayer	Reportedly looking for solutions to assure accessibility to patients. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Zytiga	Abiraterone acetate	Treatment of prostate cancer	Janssen	Accelerated approval by the EMA. Recognition of added therapeutic value.
Imbruvica	Ibrutinib	Chronic lymphocytic leukaemia	Janssen	Breakthrough therapy designation by the FDA. Recognition of added therapeutic value.
Imbruvica	Ibrutinib	Mantle cell lymphoma	Janssen	Breakthrough therapy designation by the FDA. Recognition of added therapeutic value.
Olysio	Simeprevir	Chronic hepatitis C	Janssen	Recognition of added therapeutic value. An estimated 300 patients missing Harvoni (sofosbuvir)
Velcade	Bortezomib	Patients with non-previously treated multiple myeloma	Janssen
Velcade	Bortezomib	Previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant. In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;	Janssen	Therapeutic standard in all guidelines. Recognition of added therapeutic value.
Sylvant	Siltuximab	Treatment of multicentric Castleman’s disease in adults who tested negative for the human immunodeficiency virus (HIV) and the human herpesvirus-8 (HHV-8)	Janssen	Orphan disease –roughly 9 patients each year. Recognition of added therapeutic value
Sirturo	Bedaquiline	Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).	Janssen	New molecule for tuberculosis. Orphan disease –roughly 3 patients each year. Recognition of added therapeutic value
lynparza	Olaparib	First oral treatment for women with BRCA-mutated advanced ovarian cancer who have received 3 or more prior chemotherapy medicines	AstraZeneca	Oprhan drug. Currently undergoing economic evaluation. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Toujeo	Insulin glargine injection	Used to treat diabetes in adult patients	Sanofi-Aventis	New formulation. Waiting decision on charges limit.
Keytruda	Pembrolizumab	used to treat adults with melanoma that has spread to other parts of the body or cannot be surgically removed.	Merck	Formal negotiations with INFARMED have begun, and a final proposal has been reached.
Zontivity	Vorapaxar	Used to reduce the occurrence of atherothrombotic events such as further heart attacks or strokes in adult patients who have already had a heart attack. It is given in combination with aspirin and clopidogrel.	Merck	Under pharmacoeconomic evaluation
Isentress	Raltegravir	Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children,toddlers and infants from the age of 4 weeks	Merck	Under pharmacoeconom ic evaluation
Genoya	Elvitegravir/Cobicista/Emtricitabine/Tenofovir alafenamide	HIV-1	Gilead
Zerbaxa	Ceftolozane and tazobactam.	Antibiotic used to treat adults with complicated (difficult to treat) bacterial infections affecting: ·        tissues and organs within the belly (intra-abdominal infections); ·         the kidneys (pyelonephritis); ·         the urinary tract (structures that carry urine, such as the bladder).	Merck	Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Adempas	Riociguat	It is used to increase the ability to carry out physical activity in adults with Chronic thromboembolic pulmonary hypertension and Pulmonary arterial hypertension	Bayer
Jardiance	Empagliflozin	Type 2 diabetes	Boehringer Ingelheim
Pradaxa´s third indication	Dabigatran etexilate	Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults	Boehringer Ingelheim
Eylea	Aflibercept	Diabetic macular edema	Bayer	Currently in contract negotiation. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Eylea	Aflibercept	Occlusion of the central retinal vein	Bayer	Currently in contract negotiation.
Stelara	Ustekinumab		Janssen	New indication. Equivalent added therapeutic value
Rezolsta	Darunavir / cobicistat	Human immunodeficiency virus type 1 (HIV-1)	Janssen	New fixed association. Equivalent added therapeutic value
Triumeq	Abacavir, dolutegravir and lamivudine	Human immunodeficiency virus type 1 (HIV-1)	ViiV Healthcare	New fixed association. Equivalent added therapeutic value

Portuguese cancer patients with good access to breast and lung cancer drugs, report shows

 

By Marcio Barra

A new report detailing patient access to cancer drugs across Europe has shed some light on the numbers for Portugal, and how does it compare to other countries.

The report, “Comparator report on patient access to cancer drugs in Europe revisited”, conducted by the Swedish Institute for Health Economics, gives an overview on the consumption and spending on cancer drugs across European countries, divided by cancer type. The report´s data encompasses 1995 to 2014.

Highlights of the report include:

• The number of people diagnosed with cancer continue to increase in Europe, with cancer incidence totaling 7 million in 2012, up by 30% from 1995.

• Mortality rates are going down in relative terms, owing to advances in cancer treatments available today. These include multimodal therapy approaches, improved care by multidisciplinary teams, and improved diagnostic and screening methods that have facilitated early detection of tumors.

New first-in-class antibiotic Zavicefta approved by the European Comission

By Marcio Barra

A new antibiotic has been approved for use in the European Union to treat patients with serious Gram-negative bacterial infections requiring hospitalisation.

The drug, Astrazeneca’s Zavicefta, is a fixed combination of avibactam, a new beta-lactamase inhibitor, and ceftazidime, a third generation cephalosporin antibiotic already approved for use in the European Union.

Multidrug-resistant Gram-negative bacteria are increasingly encountered globally, posing serious health risks to the population. The inhibition of the action of beta-lactamases, which play a key role in the development of bacterial resistance, is a standard method of fighting bacterial infections.

Avibactam is a first-in-class non-β-lactam β-lactamase inhibitor. The drug restores the in vitro activity of ceftazidime by protecting it against Ambler class A, class C, and some class D β-lactamases produced by bacteria. The drug has a similar mechanism of action to other β-lactam inhibitors available, acting through covalent modification of a catalytically important nucleophilic serine residue. However, unlike the β-lactam inhibitors, avibactam reacts reversibly with its β-lactamase targets.

Zavicefta was approved by the European Medicines Agency back in April for the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); Complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. This approval by the European Commission allows Astrazeneca to market the drug in all 28 European Union countries as well as Iceland, Norway and Liechtenstein.

Zavicefta is being jointly developed by AstraZeneca and Allergan; AstraZeneca holds the global commercialisation rights, with the exception of North America, where the rights are held Allergan. The drug is already approved in the US by the Food and Drug Administration for the treatment of cUTI including acute pyelonephritis, and complicated intra-abdominal infections. Approval for the drug was based on two Phase II studies, with Phase III results only recently becoming available.

Sources:

Astrazeneca press release

The road to avibactam: the first clinically useful non-β-lactam working somewhat like a β-lactam.

 

 

Useful documents tab now available on Pharmupdates – BMJ journal template and Endnote style

By Márcio Barra

Over the years, I have created a multitude of documents to help me in my projects. I have thus decided to create a useful documents tab to go along with my articles on medicines tab, which is by far the most popular tab of Pharmupdates.

To quick start the tab, I have published both a Word template and an Endnote Style for anyone looking to submit articles to the British Medical Journal (BMJ). I will be updating the tab with new documents that I feel would be useful to someone.

British Medical Journal (BMJ) journal template and Endnote style

I created both a Word template which I used for the submission that has all the required fields for a Research Article (this includes systematic reviews as per the journal rules). I also created an Endnote style, since the link that the journal provides is broken, and the one provided in the Thomsom Reuters website is incomplete.

If you require assistance with the submission procedure (formatting, image creation, referencing) contact me.

For the BMJ Endnote style and template, send me an e-mail.

Five in critical condition and one in coma after testing with Portuguese medicine BIA 10-2474

By Márcio Barra

Six people were hospitalized in the Hospital of Rennes, France in serious condition, and one is brain dead, following a Phase I first-in-man clinical trial with a new drug  from the Portuguese pharmaceutical company BIAL.  The clinical trial was being conducted by French company Biotrial.

The French Health Minister, Marisol Touraine said on Friday that it is a “serious accident”. The minister added that the accident happened on Thursday and that the trial was suspended, with all previous volunteers called to undergo tests.

There are several reports online describing the drug as an analgesic product based on cannabis, but little to new additional details are being reported. Looking at BIAL´s R&D pipeline, the agent appears to be BIAL´s BIA 10-2474. BIA 10-2474 is described as a new small molecule drug that acts on the Central Nervous System as a painkiller, and currently undergoing Phase I trials.

Reports state that a total of 8 participants were participating in the trial, with two taking placebo. A message on Biotrial´s website reads:

During a FIM study which was being conducted for a sponsor, serious adverse events related to the test drug  have occurred in some subjects at our CPU. The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital. We are in close and regular contact with the Health Authorities and Ministry in France. The priority at Biotrial remains the safety of our subjects. We are very grateful for the support we have been receiving from our clients and partners today.

BIAL is still verifying the occurrence, since the drug has been used successfully in other subjects with no issues.

45 novel drugs approved by the FDA in 2015

By Márcio Barra

Savaysa, a novel anti-clotting agent made by Tokyo-based Daiichi Sankyo, and the first new molecular entity to be approved by the FDA in 2015

Novel drug approvals in the US reached a new high in 2015, with 45 new medicines containing new molecular entities approved by the Food and Drug Administration, above the 2014 figure of 41, the record held since 1996. Moreover, of the 45 new approved drugs, more than 40% of new approvals were for rare disease therapies.

IMS Health expects this rising trend of approvals to continue in the coming years, with with 225 new drugs expected to receive clearance between 2016 and 2020, compared to 184 for the 2011-2015 period.  Cancer treatments are expected to be the largest category of new drug approvals.

The full list (still under construction) is provided below:

651 Portuguese Hepatitis C patients cured since the introduction of Sofosbuvir

By Márcio Barra

Sofosbuvir, Gilead´s Hepatitis C drug which is making waves due to its high cure rate (approximately 90%) and high treatment cost, has already cured 651 Hepatitis C patients in Portugal since it was made available, according to the National Competent Authority INFARMED to Diário de Notícias.

The drug (marketed as Sovaldi for the Sofosbuvir-only formulation, and as Harvoni for the combination of Ledipasvir and Sofosbuvir) was made available following an agreement between the Ministry of Health, INFARMED and Gilead Sciences to treat 13,000 hepatitis C patients. The agreement was concluded on February 2015 following weeks of negotiations. So far, 5322 patients are currently undergoing treatment, with 683 reaching the end of treatment. 32 patients were not cured of Hepatitis C, and hospitals have not reported the causes for the non-response to treatment. As for the total cost of payment per patient, the amount remains undisclosed.

In Portugal, it is estimated about 100,000 people are living with hepatitis C and a large proportion of them have developed cirrhosis. The prices of Sofosbuvir across European member states- in excess of €50,000- make Sobusfuvir a heated topic of discussion among healthcare regulators.

Advisory Boards in the changing landscape of Medical Affairs

Guest article by Anabela Farrica

The Medical Affairs (MA) function is known to be a rather broad and hard one to define. (1)  Its operations are essentially founded on the scientific exchange with internal and external stakeholders, with the ultimate goal of translating medical science into value – not only value for the business, but also, and most importantly, value for the patient through an adequate and safe use of their products. The methods MA groups employ to support and fulfill this goal are of great diversity: scientific congress support; advisory board realization; data generation (by providing support to both pre- and post-marketing studies); implementation of educational programmes for healthcare professionals (HCP) and patients; promotional material review; providing answers to medical enquiries; and many others. (2)

The success of a MA group is highly dependent upon the understanding, by its members, of how the regulations surrounding their activities apply and, at the same time, of the commercial implications of their work. (1) Maintaining this delicate balance is no small task, especially considering the intensified public and regulatory scrutiny applied to the pharmaceutical and medical device industries. (3)

Furthermore, the job of MA has become increasingly complex, not only because of this scrutiny on the industry, but also because there is a host of external challenges that increases the expectations for these professionals:

• HCP’s information needs have grown and become more demanding; (4)
• A sharper focus on Risk Management; (5)
• The growing prevalence of chronic diseases; (5)
• An increased industry focus on niche diseases, with products characterized by a larger amount of complex scientific information; (5)
• The emergency of new types of data (e.g. Real World Data) and an expanding number of its users; (6)
• A rise in digital media as sources of medical information that have made patients a pivotal stakeholder in today’s industry communication initiatives. Specifically, there is a growing interest on the patient’s satisfaction as a consumer of care. (5)
• A more demanding market access environment, with strict pricing and reimbursement policies that difficult access to the often costly therapeutic novelties. (5)

Additionally, the focus of a MA team on the sound scientific interpretation of drug-specific and data-specific information and its implications has been recognized by the companies has a valuable asset for strategic planning. In this role, the MA professionals have become crucial by helping to bridge science with commercial aspirations. (6)

In the face of these challenges, MA’s purpose of enhancing medical care will not only require a deep comprehension of product knowledge, but also a robust, informed view of the needs, requirements, expectations and perspectives of various healthcare stakeholders. (7) Advisory boards, while not a novelty for MA teams, are of particular relevance as a strategy for obtaining non-binding but informed guidance on a range of business aspects. (8)

Advisory boards are commonly held with Key Opinion Leaders (KOLs) in the company’s fields of expertise in order to obtain expert feedback on various aspects related to a product or disease state. (2) An effective advisory board is a precious tool to gain insights on possible research opportunities, including guidance on clinical development and trial protocols, as well as unmet medical needs that might drive future clinical strategies. Input on marketing strategies, plans or materials can also be acquired through these meetings. (2, 7) By allowing a direct engagement with the medical community, advisory boards help pharmaceutical companies in product development, data generation, strategy refinement and in creating relevant and reliable educational and promotional content. (7)

Advisory boards can, thus, take place virtually at any stage of product development, depending on the needs identified by the company. However, as the regulatory requirements get tougher and payers look for ever more clear-cut proof of products’ value, MA should seek out to include insights from a broad range of external medical decision-makers and influencers into early clinical development. (7, 9) Expert input might guide, for instance, the risk management plan for clinical trials and the identification of the ideal target groups for the product, to ensure optimal clinical effect is achieved. The importance of this input grows as the a product moves along the development and regulatory pathways – especially as it progresses onto Phase III or Pivotal Clinical Trials, which are often determinants of product success. It might be beneficial to taken this type of advice from both Global and Regional advisory boards, to take into account regulatory and clinical differences, or even physiological variations between populations. (10)

Once a drug is licenced, advisory boards might be useful to: (2)

• Understand the appropriateness and effectiveness of marketing strategies;
• Identify and design the necessary post-marketing clinical trials;
• Perfect the medical and/or patient education measures that have been adopted;
• Increase understanding of how satisfied physicians and patients are with the product and of how to best fill in the gaps and voids that may exist.

A successful advisory board is one that generates actionable deliverables and that fosters positive relationships with prominent members of the scientific community. (7) The trend for tighter budgets and the pressure to do more for less represent great challenges to MA professionals. To maximize the return on investment, it is important to invest optimal resources in structuring an advisory board appropriately. (8) Cost reduction should not mean that meeting quality is compromised, as poorly executed advisory boards fail to provide companies with instructive medical insights and added-value recommendations from the medical experts in attendance. (7) Some of the elements to consider in an advisory board to ensure the desired outcomes are:

1. Have a clear objective: the MA team responsible for organizing the advisory board must set a focused goal that not only justifies holding the meeting, but will also determine its members and guide the discussion. (11)
2. Choose the right people: ideally, the group of advisors should be representative of the variety of skills, expertise and experience related to the specific topic under discussion. This means that the board should not necessarily consist of product supporters only, for example. In some cases, the best insights and ideas come up when opinions diverge. (7) Having members that are good communicators and are open-minded is also important to foster discussion. “Big names” can be a powerful addition to an advisory board, but an uneven peer group, with a mixture of elements with various levels of notoriety or responsibility, may create barriers instead of opportunities. (12)
3. Clarify expectations: when inviting an expert to join an advisory board, it is essential to lay down the expectations the MA team has for the meeting in terms of time, areas where help is being sought out and end result. If the object of discussion includes private information, members should be notified of the need to sign a confidentiality agreement. (12)
4. Compensate the participants: money should not be the main motivator for participation in an advisory board. Nevertheless, it is good form to provide some sort of compensation, such as meals, travel expenses or even a small fee. Members that feel appreciated will be more willing to engage in active discussion. (12)
5. Make sure board members are prepared: distributing information to board participants before the meeting increases the chances of an interactive, successful meeting. (11) Pre-readings or other materials ensures that all participants are equally prepared, thus facilitating the flow of the session and promoting an active and open participation by the group.
6. Assign a great moderator: preferably a person from the MA team that is familiar with the details of the issue for which input is being collected. This helps energizing the meeting onto an end result that is effective and actionable. (7)
7. Organize the meeting appropriately: from a member-driven agenda that stimulates interest to a meeting location that is comfortable and free of distraction, a carefully thought out meeting is essential to maximize potential benefits. (12)
8. Diversify the communication methods: typical Powerpoint presentations may not work for everyone, due to the natural heterogeneity in learning and group discussion styles. Handouts with relevant graphics, videos or questionnaires are interesting alternatives to consider. (7)
9. Assess the meeting: obtain feedback immediately after an advisory board ends. Self-assessment and monitoring are key. (11)
10. Convert meeting results into action steps: in order for the core objective of the advisory board to be fulfilled, the insights gained from the meeting should be capitalized under the form of practical company activities. (7) A board where the solicited feedback results in action steps is a successful board. (2)
11. Follow-up with board participants: keeping the members of the advisory board informed on the outcomes of the meeting is vital to foster continued scientific exchange with these KOLs. Updates on what is being planned and on what the company has worked on as a consequence of the meeting should be made on a regular basis.

These practices ensure advisory boards are founded on professional dialogue and informative feedback, which can help identify key issues needing clarity or exploration and set a framework for value-added change. (13)

In the (recent) past, the biopharmaceutical industry was under a considerable amount of criticism around the unduly use of allegedly scientific advisory boards as promotional events to influence physician’s prescribing habits. Accusations of promotion of either unlicensed products or indications emerged, as well as suspicions of disproportional compensation and hospitality given the nature of the meetings. Nowadays, these and other types of interactions between the industry and healthcare professionals are governed by a set of rules: European and/or national law; companies’ Codes of Conduct; and ethical standards defined by EFPIA and by national associations of the pharmaceutical industry (APIFARMA, in Portugal) that have been increasingly advocating for a culture of transparency. (10)

Advisory boards have been a part of the MA landscape for a long time, functioning as sources of expert insight into a wide range of issues related to products’ lifecycle.  Today, they are more useful than ever, as regulatory requirements get tougher and patients, payers and healthcare providers demand more and more diverse clinical data and health outcomes information to prove product vale. Effectively managed advisory boards help MA teams to achieve this and more – as the ultimate goal of the knowledge gained should always be to improve the quality of life for patients. Biopharmaceutical companies are expected to seek and employ innovative ways of conducting advisory boards and capitalizing on the wisdom gained, so as to balance the value added to their clinical and commercial goals with the compliance with the relevant codes and laws.

References

1. Wolin MJ, Ayers PM, Chan EK. The Emerging Role of Medical Affairs within the Modern Pharmaceutical Company. Drug Information Journal. 2001;35(2):547-55.
2. Evens R. Medical Affairs and Professional Services. In: Evens R, editor. Drug and Biological Development: Springer US; 2007. p. 240-74.
3. Werling; K, Carnell; H, McCormick; D, LLP; M, Chicago I. Focus on Life Science Compliance: The Evolution of Medical Affairs Departments. AHLA Connections. 2011;15(11).
4. Bloom; L, Andre; T, Chandran; P, Dabbs; E, Keen. K. Raising the Bar in Biopharma Medical Affairs: Three Critical Success Factors Boston Consulting Groups: Boston Consulting Groups; 2013 [cited 2015 27-06-2015]. Available from: https://www.bcgperspectives.com/content/articles/biopharmaceuticals_raising_the_bar_in_biopharma_medical_affairs/.
5. Morgon P. Medical Affairs. CEGEDIM, 2014.
6. Evers; M, Fleming; E, Ghatak; A, Hartmann; J, Nathoo; A, Piervincenzi; R, et al. Pharma Medical Affairs 2020 and beyond. McKinsey & Company: McKinsey & Company, 2012.
7. Dyer; S, Tolmachev. A. Nine Key Elements To Ensure Advisory Board Success pm360online: pm360online; 2014 [cited 2015 27-06-2015].
8. Best Practices L. New Study Presents Insights to Advisory Board Effectiveness in the Pharmaceutical Sector prnewswire.com: prnewswire.com; 2015 [cited 2015 27-06-2015]. Available from: http://www.prnewswire.com/news-releases/new-study-presents-insights-to-advisory-board-effectiveness-in-the-pharmaceutical-sector-300076091.html.
9. Presson J. ADVISORY BOARD FUNCTIONS EXPANDING IN PHARMA INDUSTRY Cutting Edge Information: Cutting Edge Information; 2013 [cited 2015 27-06-2015]. Available from: https://www.cuttingedgeinfo.com/2013/advisory-board-functions-expanding-pharma-industry/.
10. Liftstream. Scientific Advisory Boards and the Impact of Compliance Liftstream: Liftstream; 2015. Available from: http://www.liftstream.com/blog/scientific-advisory-boards-and-the-impact-of-compliance/#.
11. Moltz B. 10 Steps To Forming An Effective Advisory Board American Express American Express 2011 [cited 2015 27-06-2015]. Available from: https://www.americanexpress.com/us/small-business/openforum/articles/10-steps-to-forming-an-effective-advisory-board-1/.
12. Stengel G. Ten Tips to Creating an Effective Advisory Board Stengel Solutions: Stengel Solutions; 2003 [cited 2015 27-06-2015]. Available from: http://www.stengelsolutions.com/tips19.htm.
13. Joyce D. Medical Affairs: The Catalyst for Effective Medical Communications. PharmaVOICE. 2013:46-7.

Portuguese Pharmaceutical group Bial under search for suspected payments to physicians

Dozens of inspectors of the Policia Judiciária(Judiciary Police – PJ) are conducting a search and seizure operation at the headquarters of the Portuguese Bial Group, in Porto, and at the pharmaceutical delegations in Lisbon. It was initially believe that the Coimbra delegations were also being investigated, but this is currently not the case.

The search warrants were issuedby the Departamento Central de Investigação e Acção Penal (Central Department of Investigation and Penal Action (DCIAP))and the investigating judge Carlos Alexandre.

This operation is due to a suspected corruption case involving senior executives of the Bial Group, sales representatives, and hundreds of physicians allegedly paid to participate in scientific studies and to prescribe medicinal products marketed by the Portuguese company.  These include bonuses paid to doctors for false prescriptions of drugs that benefited from a high reimbursement rate from the National Health Service, some of which reimbursed at 100%.

The operation currently only counts with search warrants, with no arrest warrants issued thus far, but according to the Público Newspaper, later today defendants might be named in this case.

The process is centered on signs of, among other crimes, active and passive corruption for lawful and unlawful action, aggravated fraud, and document falsification.

Bial´s drug portfolio includes a number of generics, from Diazepam, Acid Folic products and Rivestigmine, to the first original drug molecule developed in Portugal, Eslicarbazepine acetate (marketed as Zebinix in Europe and as Aptiom in the US), for the treatment of epilepsy, and the upcoming Opicapone, a COMT inhibitor for Parkinsons´s Disease.

We will update the website as the news progresses.

Portuguese hospitals required to create a Research Service until 2016

July 6, 2015 | By Márcio Barra

Many hospitals in Portugal lack adequate support services for Clinical Trials. (Image source: Roche.pt)

All Portuguese hospitals will have to create a Research, Clinical Epidemiology and Public Health service until June 2016, and bigger hospitals will have to do so until the end of 2015, according to Order (extract) No 7216/2015, published on July 1st on the Diário da República website.

This requirement comes from the fact that the majority of hospitals and health centers in Portugal do not have oriented services to support these kinds of research activities, such as clinical trials, observational trials, and epidemiological studies . These new units are an attempt to fill this gap, and as such, the responsibilities of the Research, Clinical Epidemiology and Public Health services will include:

• Collaborate in the provision of hospital care and activities that promote general health in the population, including planning, monitoring and evaluation of health care and organization of health services
• Support and promote the participation of the hospital in which they are inserted in public health programs
• Support for epidemiological, clinical, public health and health care research activities, by providing research enterprises for health professionals, training in research methodology, promote good research practices, and providing human and logistical capacity for research activities
• Promote hospital collaboration in research projects led by third parties and participation in research networks
• Prepare hospitals for emergencies, such as epidemics, disasters or other threats to public health
• Support or ensure the planning, creation, development and management of hospital records, national health registries, and data relating to the literacy of health professionals regarding computer systems and statistics
• Propose, manage and collaborate on intervention programs for disease prevention and health protection

Moreover, a Research, Clinical Epidemiology and Public Health service will be able to include many different professional groups (physicians with experience in clinical research, nurses, and biostatisticians, among others. No mention of clinical research coordinators), which may, with the permission of the hospital board, accumulate functions with other services.  The Diário de Notícias is reporting that physicians will be able to devote 75% of their time to research activities, and that there will be incentives for physicians who purse research, such as salaries increase or career progression.

Research, Clinical Epidemiology and Public Health services should must become operational by December 31, 2015, in Hospitals, Medical Centers or Local Health Units of Groups III and IV, according to Decree No. 82/2014 of April 10. These include:

• Centro Hospitalar e Universitário de Coimbra, EPE
• Centro Hospitalar de Lisboa Central, EPE .
• Centro Hospitalar Lisboa Norte, EPE
• Centro Hospitalar de São João, EPE
• Centro Hospitalar Porto, EPE .
• Instituto Português de Oncologia de Coimbra, Francisco Gentil, EPE
• Instituto Português de Oncologia de Lisboa, Francisco Gentil, EPE
• Instituto Português de Oncologia do Porto, Francisco Gentil, EPE
• Centro de Medicina Física de Reabilitação do Sul
• Centro de Medicina de Reabilitação da Região Centro – Rovisco Pais
• Centro de Reabilitação do Norte
• Centro Hospitalar Psiquiátrico de Lisboa
• Hospital Magalhães de Lemos, EPE

All remaining Hospitals, Medical Centers or Local Health Units have until June 30, 2016 to implement this service.