The BERC-Luso Project (Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries) is currently in its 4th year, that will lead the project to its end, by carrying out the last Work Plan 4 - De rete / Networking.

The BERC-Luso coordination team will visit each of the partner countries, fulfilling the requirements of the project to assess its real impacts in Angola, Cabo Verde, Guinea-Bissau, Mozambique, S. Tomé and Príncipe. At the same time, BERC-Luso trainees in each of the partner countries are preparing an on-site programme to promote and disseminate the project but, above all, to train their colleagues and fellow colleagues. This will be a demanding programme to be prepared as a team, with anticipation and dedication, and suited to the target audience. This last work package aims at deepen the levels of connection between all partners and those of external dissemination of the project, consolidating long lasting and sustainable bases for effective and wide exchange, ensuring constant updates and continuous education and training.

The first official visit will take place in São Tomé and Príncipe between 28^th February and 4^th March. The visit plan includes meetings with the country's national authorities and high-level meetings the political stakeholders, a meeting with the Portuguese Ambassador, a public event on clinical trials and biomedical research with the participation of the São Tomé and Príncipe BERC-Luso team and the BERC-Luso coordination, and visits to several national entities relevant to the project.

Visit the website www.berc-luso.com to keep up with the latest developments of this project!

The BERC-Luso Project joined the 10^th EDCTP Forum - Equity in research for health, from 17^th to 21^st October, in Mozambique, in a hybrid model between face-to-face and online format. The Project was selected to make an oral presentation on the topic "Institutional and legislative impact of BERC-Luso in Portuguese-Speaking African partner countries", as part of the panel "Capacity building, collaborations, enhancing the research environment, knowledge translation".

EDCTP has sought to promote the strengthening of the relationship between Africa and Europe, still marked by strong differences at the level of scientific research.

BERC-Luso, through its activities, intends to mitigate these differences by collaborating with the five African countries (Angola, Cape Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe) in order to facilitate their development and strengthening of national medicines regulatory systems and capacities for ethical review of clinical research. During the Forum, the project was highly applauded, namely for being one of the few involving Portuguese-speaking African countries, often excluded from international projects.

It took place, on the 8th of July, the last webinar dedicated to the analysis of cases, presented by Prof. Helder Mota Filipe with the theme “The drug circuit in clinical trials and the protection of participants”.

The basic factors to guarantee the quality of the medicine circuit, the fundamental principles, the physical conditions, the human resources with specific training in good clinical practices and good pharmacy practices were presented, to promoting the guarantee of an adequate implementation, with the focus on the protection of participants, the robustness, the quality and integrity of the data generated in the clinical trial.

Another issue addressed was the responsibilities of the clinical trial sponsor, not only during the trial, but also after the trial, namely with the follow-up and monitoring of participants.

The new reality of clinical trials in view of the COVID-19 pandemic, the need for adaptation, the participant's rights, the record time in which vaccines were obtained, the testing of existing drugs and new drugs were also addressed. Again, the issue of informed consent in these borderline situations was discussed.

Prof. Helder Mota Filipe ended his intervention leaving several points for discussion: how to increase the number of clinical trials in PALOPs; how to create the necessary conditions for their execution; how to resolve the material and human resource requirements in the main hospital institutions and what is the possible contribution of BERC-Luso to overcome these issues. The webinar had a massive participation of all countries involved, which allowed a wide discussion of the proposed issues. This was the last webinar before internship in Lisbon, and Prof. Helder left the challenge of organizing a pilot trial in different countries. Certainly this will be a widely discussed topic in the week of September 12th to 18th.

The internship of BERC-Luso Project, “Biomedical Research and Clinical Trials: Regulatory Training and Ethics”, will take place from 12 to 18 of September, in Lisbon – Portugal in INFARMED and CEIC.

This internship consists of a 6 day´s of practical training, in a total of 50 contact hours. The program can be consulted on the link below.

The internship will take place in a face-to-face system, ensuring all precautions and restrictions within the scope of the control of the pandemic against COVID-19.

On June 17^th, another webinar dedicated to the analysis of cases took place, presented by Professor Maria Alexandra Ribeiro, who presented a case of a prospective, randomized (1:1) open and multicenter clinical trial phase IIIb/IV to assess the efficacy and safety of the drug compared to clinical practice.

The case study was based on an experimental drug capable of reversing anticoagulation due to uncontrolled or life-threatening bleeding. With the case study presented, we intended to discuss tree main issues: obtaining consent to participate in the study in view of its specificities, as well as the patients to be included (emergency situation); acceptable risk-benefit ratio under conditions where the patient is unable to provide consent; and integrity/validity of the study data, due to the possibility of bias in the results due to the exclusive inclusion of less severely ill patients that were able to consent.

It was a very participated event and although the existence of clinical trials is not yet a reality in all countries involved in the project, the desire for these to become a national reality was commonly expressed. Another issue that was also widely discussed was informed consent, not only because of how it can/should be obtained in clinical trials but in other more specific situations, namely in persons unable to consent.

The next webinar is scheduled for the 8^th of July at 17.00h and Professor Helder Mota Filipe will be in charge of the presentation.

On June 17, 2021, we will have another webinar dedicated to the analysis of practical cases.

Prof. Maria Alexandra Ribeiro (CEIC) will presented the case  and the moderation will be made by Prof. Maria do Céu Patrão Neves.

The African-European Symposium: Challenges in Research Ethics Assessment, an organization of Embassy of Good Science, took place on the 25^th of May, in collaboration with EUREC, BERC-Luso, AfriEthique and LiberHetica. This meeting consisted in four sessions, each one with a specific topic, and BERC-Luso project has been presented in three of them.

The purpose of the event was to share experiences and perspectives about the challenges of ethical evaluation in research, with African and European specialists. In session one, dedicated to Ethical education and teaching, BERC-Luso was represented with the participation of Angola (Jocelyne Neto Vasconcelos), Mozambique (Telma Chicuamba) and S. Tomé and Principe (Vânia Castro). The second session was dedicated to the Independence of research ethics committees, featured the participation of Cape Verde (Ester Delgado Oliveira) and Guinea-Bissau (Vitor Francisco Gomes) on behalf of BERC-Luso. The participation of BERC-Luso ended in the session dedicated to Research ethics challenges during public health emergencies, in which the presentation was from Portugal (Maria do Céu Patrão Neves and Maria Alexandra Ribeiro).

At the end of each panel there was place for discussion, questions, answers and even an exchange of experiences between different countries. The fact that this event involved African and European countries has provided the possibility of raise awareness of very different realities, challenges, and constraints.

It was undoubtedly a unique opportunity for each country to showcase the work that has been developed within BERC-Luso.

The LiberHetica and BERC-Luso consortia meet on the 26th March 2021 to discuss about Biomedical Ethics and Regulatory Capacity Building in Sub-Saharan African countries.

The BERC-Luso and LiberHetica are two projects funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) aimed at strenghting ethics and regulatory capacities for clinical trials by partnerships between African and European countries, and involving 5 Sub-Saharan African countries (Liberia, Angola, Cape-Verde, Guinea Bissau, Sao Tome and Mozambique) and two European countries (U.K. and Portugal).

In addition to the partner countries, Ms. Maria Hermínia Cabral and Mr. João De Almeida Pedro from the Calouste Gulbenkian Foundation, the institution that supports BERC-Luso, as well as Ms. Mariama Pinto, Third Secretary, Head of the Health and Social Affairs Department of the Embassy of Guinea-Bissau in Portugal, are also present.

The session is moderated by Professor Maria do Céu Patrão Neves and Master Jemee Tegli.

In this webinar the partner countries present the latest legislative and institutional. developments.

We present a brief summary of the changes to date.

Angola

Ethical Regulation:

• Revision of the proposed Law on Clinical and Biomedical Research, after the opinion of MINSA's Legal Office;
• Creation of the DNME/INIS technical group to create standards for research on medicinal plants with potential use in the treatment of covid-19

Legislative framework:

•  The approval of the proposed Presidential Decree on pharmacovigilance is awaited and has already been sent to the MINSA;
• Awaiting approval of the proposed Medicines Law, already submitted to the MINSA;
• Approval of the proposal for a Presidential Decree that creates the Medicines Regulatory Authority is awaited
• Publication in “Diário da República” of the Regulation for the Registration of Medicines in Angola, in accordance with Presidential Decree No. 315/20 of 17^th December.

Cape Verde

• Discussion between ERIS and CNEPS of strategies to promote, with the Ministry of Health and Social Security, the drafting of a Clinical Research law;
• At this moment, the creation of a working group is pending

Legislative framework:

• The drafting of the Clinical Research Law is pending.

Guinea Bissau

• The Possibility of constituting a working group for the approval of the law on research and health.
• The Possibility of Legalizing the National Institute of Public Health (INASA)

 São Tome and Príncipe

• The Minister of Health approved the proposal for the establishment of a Pharmaceutical Regulatory Authority
• The proposal was submitted to the Council of Ministers and also approved;
• It is currently under consideration in the National Assembly for its approval.

On the 11^th of February takes place the session "Legislative and Institutional Impact of BERC-Luso in the PALOP", at 05:00 pm (GMT), through the zoom platform.

In this webinar the speakers present the latest legislative and institutional developments in the respective partner countries.

Ms. Joana Morais (INIS - Angola), Ms. Ester Oliveira (ERIS - Cape Verde), Mr. Mouhammed Ahmed (INASA - Guinea-Bissau), Mr. Jeryson Ramos and Ms.  Vânia Castro (MS - Sao Tome and Principe participate in the event.