1. What is this Preliminary Market Consultation looking for?

The presentation of innovative proposals aimed to answer a series of challenges through the use of technologies that exceed the benefits of those currently existing in the market.

These proposals will serve to evaluate market capabilities and define functional specifications that imply innovation and are feasible to be achieved through an eventual Public Procurement of Innovation or other public procurement instrument.

The purpose of this type of procedure is not the reception of offers, but the reception of solutions that help to solve the needs not covered in the Andalusian Health Service.

2. This Preliminary Market Consultation includes selection criteria?

The Consultation does not have selection criteria. There will be specific criteria in future tenders.

3. What kinds of solutions are needed, and how far they should be from what it is already available in the market?

Initially, the idea is not looking for how far away from the market or how closer to it a solution is. It is more important that solutions are innovative and aimed to solve the problem or improve the public service.

4. Participants who do not have a registered office in Spain, how do they participate? Would they have problems when opting for the future Public Procurement of Innovative Solutions?

The call for consultation is open to all natural or legal persons. For the future tender, they will have the capacity to contract with the public sector those indicated in the law of public sector contracts (CHAPTER II: Capacity and solvency of the entrepreneur), in addition to the Spanish ones, in any case, the non-Spanish companies of the Member States of the European Union or of the signatory States of the Agreement on the European Economic Area which, in accordance with the legislation of the State in which they are established, are qualified to perform the provision in question. When the legislation of the State in which these companies are established requires special authorization or membership of a certain organization to be able to provide the service in question, they must prove that they meet this requirement. Without prejudice to the application of Spain's obligations arising from international agreements, natural or legal persons of States not belonging to the European Union or States signatory to the Agreement on the European Economic Area must justify by means of a report that the State of origin of the foreign company also admits the participation of Spanish companies in contracting with public sector entities similar to those listed in article 3, in a substantially analogous manner. Said report shall be prepared by the corresponding Economic and Commercial Office of Spain abroad and shall be accompanied by the documentation submitted. In contracts subject to harmonized regulation, the report on reciprocity in relation to companies of signatory States of the Agreement on Government Procurement of the World Trade Organization will be dispensed with. In addition, the list of specific administrative clauses may require non-EU companies that are awarded contracts for works to open a branch in Spain, with the designation of agents or representatives for their operations, and that are registered in the Commercial Registry.

5. Could companies that submit themselves to the preliminary consultation, eventually sub-contract a Public Research Organization (PRO) at any point of the development of the prototype? Or are these types of subcontracting not considered?

Yes, subcontracting is possible. However, if you want to contract an activity with a research center dependent on the Andalusian Health Service, a situation of conflict of interest may arise. For this, an internal regulation has been generated that regulates and analyzes these situations and thus avoid possible conflicts of interest.

6. Will the information about the assistants to the workshops and proponents be published during the Consultation?

It will be published on the SAS web page in an informative way.

http://www.juntadeandalucia.es/servicioandaluzdesalud/principal/documentosAcc.asp?pagina=pv_cpublica_innovacion_documen&url=proveedores/cpublica/innovacion_documen.htm

1. How can you obtain the application form, announcements and other official documentation?

It has been published on the Junta de Andalucia web page in an informative way.

https://www.juntadeandalucia.es/temas/contratacion-publica/perfiles-licitaciones/consultas-preliminares/detalle/000000086198.html

2. Is it possible to submit several proposals?

It is possible, both to present a solution that meets the needs of more than one need, and to present several proposals for each of the needs that apply.

3. Is it possible to present a proposal in collaboration with another entity?

It is possible both to present a proposal individually (to face the project independently) and jointly (to approach the project in a comprehensive way in a collaborative network format or another that is considered).

4. Does it link the submission of a proposal for a future contracting process?

Possible future contracting procedures will be open to all possible proposals that meet the established conditions, whether or not the companies have been participating in the preliminary consultation of the market. The submission of proposals in the Preliminary Consultation to the Market will not entail the generation of incentives or advantages for participating companies when awarding future contracts, nor will it be recognized as an award criterion or as a favorable ponderable value.

5. How is the confidentiality of the submitted documentation taken into consideration?

The participants will include, together with the information that they provide, their express consent so that the SAS can disseminate their participation and the questions and / or solutions raised in the consultation procedure.

However, the SAS may not disclose the technical or commercial information that, if applicable, has been provided by the participants and they have been designated and reasoned as confidential.

It will be the participants who must identify the documentation or the technical or commercial information that they consider to be confidential. Participants may designate as confidential any / s of the documents provided as annexes. This circumstance must be clearly reflected (in any way, or on the margin) in the document designated as such.

The application form cannot be confidential.

6. Will the information on the application forms in response to the market consultation (not the additional documents classified as confidential) be always published to all bidders?

It can be published. Normally, only the summary is published.

7. Can a completely confidential application form be submitted, that is to say, that can be considered by the SAS to construct the bidding documents, but that it is not published to the rest of the bidders?

No, the application form cannot be confidential (the annexes or supplementary documents can be confidential).

8. What is the sector or scope of CNAE activity?

The CNAE refers to the National Classification of Economic Activities. The entity responsible for the proposal must indicate their CNAE (if applicable). This declaration is for information only (Workshop 18th October 2018).

9. What does it mean: The tenderer's financial contribution to the initiative (€, meaning the sum of all contributions in the bidder's facilities and resources)?

This section is more specific to the type of Pre-Commercial Purchase. It refers to the means that the proponent would be contributing to the project (eg licenses, intellectual property).

10. What does it mean: Share intellectual property rights with the contracting agency or to establish royalties on sales?

There are pre-existing property rights that belong to the entities, there may be pre-existing properties of the public buyer and finally, those that are generated within the framework of the collaboration. The entity must present in the proposal its intellectual property management model (the pre-existing one that the entity has and the one that will be generated within the framework of the collaboration) that it considers appropriate.

The intellectual property will be regulated in the future tender.

Regarding the regulation of the management and transfer of the results of the research activities of agencies and entities dependent on the Ministry, it is recommended to review Decree 16/2012, of February 7, which regulates the management and transfer of results of research, development and innovation activities whose ownership corresponds to the agencies and other instrumental entities dependent on the Ministry responsible for health.

11. What is the format to submit the applications and attached documentation?

The presentation format will be in Word or pdf.

12. Can offers be submitted with partial solutions that only give a solution to part of the requirements listed?

Yes. Proposals with partial solutions can also be submitted.

13. Can the research groups participate in the proposals?

In fact, any physical or legal person may participate in the Consultation. However, a research center that is dependent on the Andalusian Health Service can generate a situation of conflict of interest for a future tender.

To this end, an internal regulation has been created that regulates these situations and thus avoid conflicts of interest.

14. Once the application is submitted, what are the next procedures?

After the preliminary consultation, the results of the consultation shall be publicized, respecting the principle of confidentiality.

If it is considered appropriate, it will be possible to start with the drafting and processing of the tender (s) based on the ideas of solutions collected as a result of the consultation.

In any case, these procedures will be open to all possible proposals that meet the established conditions, whether or not they have been linked to the preliminary consultation to the market.

15. Is it possible to answer the form in English?

Yes, the languages ​​accepted in the process are Spanish and English, so the documentation, including the application form, can be presented in English.

16. How to present a proposal? It is possible to use links or platforms to send big files?

Proposals must be sent to: compra.innovacion.sc.sspa@juntadeandalucia.es.

For big files (over 10MB), you can use platforms as WeTransfer, Dropbox,,.... In this case, it is mandatory to send the application form (questionnarie) and a descriptive listing of these files to previous e-mail address.

17. In “Exploitation Rights of Intellectual and Industrial Property” section, what does it mean that you can not mention a manufacturing or specific origin or concrete procedure, nor refer to a brand, a patent or a type, a certain origin or production?

The content of the proposals must be described from a functional perspective. Although mention of specific technical requirements can be included; neither brands nor especially specific products should be mentioned. The use of the content of the proposals is exclusively limited to prepare the later public procurement process, and it cannot bring benefits for any participant in the Preliminary Consultation.

18. What does “other agents” in the section: “Benefis of the proposal for other agents (max. 850 characters)”?

It refers to other entities (in a broad sense) that could be benefited (directly or indirectly) by the proposal. 
For example: customers, patients, research institutes, collaborating entities, associations,… The objective is to highlight de benefits (direct and indirect) of the proposal.

19. Do the sections on “Project characteristics and planned scope” refer to the proposal of the entity or to the global preliminary consultation?

It is essential to know the characteristics and scope of the specific proposals received, which can be oriented in a partial or a global solution. Contribution about global consultation can also be described.

1. What is the deadline to submit proposals?

The deadline for submission of proposals is the 2nd of November, at 23:59 p.m. 

2. The "End Date" 03/January/2019 that is indicated in the profile of the contracting party to which it refers?

It refers to the orientation date for the end of the Consultation process, not the deadline for submitting proposals.

3. Why was the consultation end date extended to 31th of May 2019?

La fecha de finalización de la consulta se amplió debido a la amplia participación en la misma, lo cual ha requerido de un mayor tiempo para el correcto análisis, entendimiento y concreción de las soluciones propuestas.

4. Will the participants be notified of new information regarding the progress of the preliminary consultations?

Notifications will be sent out using the appropriate channels.

5. With regard to interviews with proponents to gather more information, will they be before or after the deadline for applications?

The interviews will be carried out once the deadline for receipt of proposals has expired.

6. Will all the proponents be called for an interview?

No, only those entities with attractive proposals will be cited and it will be necessary to gather more information in detail.

7. What are the bidding times?

Approximately, second quarter of 2019.

8. What will be the bidding budgets?

1,7 millones (BIOPSIA LÍQUIDA) (Provisional data)

9. What are the execution deadlines?

There is a temporary execution margin of approximately 30 months.

10. Does it link the delivery of a proposal for a future procurement or tender process?

The proposals will determine the lines of future tenders. However, the proponents will not have any type of advantage in the final hiring process due to their participation in the consultation.

11. Will all elements of the project be submitted in a single tender or will several bids be published sequentially?

After the preliminary consultation, during the drafting of the tender/s and, according to the ideas of solutions collected as a result of the consultation, it will be possible to decide if one or several tenders will be necessary.

1. Annex II describes the different types of cancer on which prototype will focus: firstly, would be breast and colon and, eventually, lung, prostate and pancreas. Could it be possible to focus on other types of tumors?

Priority will be given to breast, colon or lung cancers at advanced stages. Different proposal of another types of cancer could be considered but will not be prioritized at this phase.

2. If the prototype focuses on another type of cancer (not one of the 5 named in Annex II) and the detection system means a significant improvement over what is currently being used, could it be consider funding it?

In this phase any proposal will be accepted, but its funding will not be prioritized if it is not among those named in the previous question.

3. The product being sought falls within the category of product considered IVD. Therefore, in order to go to the market, the product must demonstrate three requirements: analytical validity, clinical validity and clinical utility. Will these requirements be considered in the moment projects were presented? What could it happen if the prototype lacks in dealing with any of them? 

The SAS mainly interest is clinical utility. However, the proposals may address any of these analyzes if they consider it appropriate.

4. What does "transverse protocol of incorporation into the system" means?

Currently, there is no standardized work protocol that addresses clinical implementation, so it should be developed simultaneously, not only the integration of the appropriate hospital system but a protocol that facilitates the management of information and the integral management of the process.

5. Is it considered that the Liquid Biopsy tests may be conducted in Andalusia?

No specific scheme has been raised at this time. It would be interesting to propose the best possible options in the proposal.

6. Would it be more effective to work with free cDNA instead of with tumor cells?

They are complementary since they offer you complementary information.

7. What type of Purchase will it be?

Pre-commercial Public Procurement.

8. Are other blood biomarkers that are different to free DNA and CTCs allowed?

cDNAs and CTCs will be considered preferable because they to have proven clinical evidence. However, the proposal is not closed and the feedback collected in this Preliminary Consultation process will be important.

9. How many samples per year are considered necessary?

It is proposed that the System developed can be used in the future in Andalusian Healthcare Systems. In this sense, sustainability is a key factor.  Volume expected per year:  8,000 patients (for instance 200-300 new cases per year with breast cancer) and 50,000-80,000 samples per year if you considered the follow-up of patients.